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Everybody. Welcome back to Palm Peeps. We are

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back after taking a brief hiatus, a 2

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rest and recover after Ats. It was an

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awesome conference. But feel like I just got

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back on my feet afterwards. Let maybe be

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our guests can share our same experience, but

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it's awesome to do back with a great

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episode. I'm looking forward to. Hey, Monty. How

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are you doing? I pay for doing well.

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I, I know I feel like I did

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a few weeks for the social battery could

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recharge. But really excited to be back today,

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and I think we're gonna have a fantastic

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episode. And today we're gonna be talking about

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pre oxygenation methods for endo

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intubation, and the pre trial which is hot

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off the press in the New England Journal

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Medicine, and for the potentially widespread practice changing

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results. If you like this is the talk

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of the town

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amongst Pcc,

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I think, Nationally and internationally. And we're so

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lucky to be joined by 2 of the

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authors of the trial. So first, let's meet

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our guests. Yeah. Absolutely. Before Hear, Guys, I'm

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just gonna comment, this is the first episode

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we're actually recording video as well. This should

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be available on Vu yeti and Youtube. If

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it's not, it's because we mess something up

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and don't hold me to this. But yeah,

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if very interested in watching no saga about

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this, then you should be able to check

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it out there. But now is evidence. So

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first, we have Doctor Kevin Gibbs. Kevin is

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an associate professor of Medicine at Wake forest

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University's full medicine. He... Obtained his Md at

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George Wash University school medicine and completed his

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residency and fellowship in Pcc at Johns Hopkins.

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He's an active researcher in critical care Ari

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ards mechanical Ventilation, and pragmatic trial design. Thanks

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for coming on the show today, Kevin. Yeah.

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I'm delayed to be here today. I'm also

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recovering from Ats that I fully recharged That's,

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back to a hundred percent. I love it.

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Welcome, Kevin. I should've have asked we shouldn't

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mask for your autograph at Ats. But just

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opportunities for months. But so delighted to next

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introduce doctor Jonathan Casey, Jonathan is in the

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system professor medicine for the division of allergy,

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pulmonary critical Paramedic at Van belt University Medical

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Center. He obtained his Md degree from the

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University of Louisville school a medicine, who and

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completed his residency training in Boston at B

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him the women's hospital before going to back

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to Van belt for fellowship training.

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He's a physician scientist and also has his

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master's of science in clinical

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investigation. His research focus on comparative effectiveness of

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Ic treatments, and he also has a focus

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on pragmatic trial

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and has support from the Nih and is

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after the American Thoracic Society critical care assembly

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honored to heavy on today John.

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Hey Evening Christine. Thanks for having us. We're

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excited to be here, and to talk about

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our work, and excited to be the very

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first video presentation. If you're watching the video,

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then you know why they invited Kevin at

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on screen. Yeah. Exactly right We're. We've gotta

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go to video now. This is the time.

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I... If I had doing that, perhaps, I

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would schedule my haircut.

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Right.

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I love it. So Chose is our standard

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disclaimer, As a reminder, this podcast is not

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meant for any Specific medical advice that the

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views we express today may not reflect those

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of our respective employers. And and in cases

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that we talk about will be hipaa compliant.

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Probably we won't be talking about much patient

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level data today.

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Great first. So we're gonna get started and

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excited to open up the question today with

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We're gonna be talking about pre oxygenation techniques

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prior to intubation for critically ill patients and

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the emergency departments and the intensive of care

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units.

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And Kevin, I wanna start by defining the

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scope and nature of this problem?

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And hoping you can tell us why is

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this something you interested in researching?

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Yeah. So I think Bi will know that

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emergency trachea division is really common over 1500000.0

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people are debated and emergency department or Icu

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with each year in the United States.

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Complications from this procedure are also really common

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and 20 percent of patients experiencing at,

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and 2 percent experienced cardiac arrest.

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There there are very few procedures that internal

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medicine or pulmonary critical care doctors do, where

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you know that in the next 2 minutes.

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1 in 50 patients will die. And so

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this is a whole really important question and

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it's a really big pro.

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Yeah. Absolutely. I think that, certainly, as you

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get experienced these, mh, our procedures that are

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done commonly and people can do them confidently,

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but it's... Probably the most anxiety provoking procedure

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that we do, just given the a nat

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nature and severity of the illness so a

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huge topic important to for us to have

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the optimal strategy.

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So in this trial, you as we're investigating

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you exactly that at the optimal strategy for

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pre oxygenation to try to avoid that par

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intubation hypo

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and then the most more severe consequences like

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a cardiac arrest.

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In general, I think fractionation was a super

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fun topic that comes up with intubation. I

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like to talk about it with have medical

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students in a residents about how much if

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you reaction, you don't need to breathe. So

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we're paralyzing these patients, but So I last

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them. What's the longest someone can hold their

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breath. And I think the world record now

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is something around 23 minutes if they allow

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pre issue and you just... If you can

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do a hundred percent oxygen each and our

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bodies are very good at this and being

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able to have quite a big reserve without

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breathing.

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However, obviously, our patients in the Are not

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competitive divers who can hold their breath for

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23 minutes, and we have a a much

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smaller narrower window. So, John, before we go

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ahead and show where you guys invested could

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you discuss the various methods of pre fractionation

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that have existed before this, they're posing cons

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and which we're are commonly used in the

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Ed.

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Yeah. I a great question. So the most

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commonly used methods of pre action are face

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mask oxygen of which there are several subtype

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type, so there's a knob breather mask. Or

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a bag mass device.

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And those of the most commonly used methods

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of fractionation. Those are used in about 70

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percent of patients in global regis registry I

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think that coming out of the operating room

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where you're right where it's very easy to

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pre patients, those have been considered by many

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people to be sufficient. However, as we know

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many of our patient or hypo hypoxia even

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on those devices and as soon as they

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become apt, they rapidly develop hypo.

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But there's been a an interest in using

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word advanced methods of preoccupation like non eva

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ventilation that's still only used in about 15

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percent of patients globally, and many of those

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patients are not used just for the 3

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minute fractionation device, but it had been on

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that device, if for support leading up to

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the point of intubation.

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The pros and cons of each device, as

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something like a non breather is really easy

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to set up. It takes very little technical

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know how to to place an on a

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breather, and there's no risk of, any complications

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like aspiration.

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But a, non invasive ventilation has other potential

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advantages. So it it provides... It guarantees a

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hundred percent oxygen and, prevents any and trained

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error. It provides positive pressure, which can recruit

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lung, and it also can provide ventilation when

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a patient's acting. Now the potential downside of

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non invasive ventilation is this hypo

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risk of gastric insulation and aspiration, and I

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think that historically that's been 1 of the

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reason people. 1 of the reasons people have

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been reluctant to use it as.

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Thanks so much, John for walking us through

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that. And first just going back to your

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comment about how long you can kinda hold

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the breath. I feel like 1 of our

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Ic teams had a a friendly spirited

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competition with that. I it wasn't 23 minutes.

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I think maybe the the winner wasn't entered,

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and it was around 5 minutes. But I

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anticipate this may be, a theme going forward.

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Yeah. It's 7 impressive 5 minutes. I can

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do that. Even with docs.

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Oh, Done, that was really helpful If you're

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about the the pre oxygenation method that we

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have available. And turning a little bit toward

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the trial itself. So we previously had some

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of your colleagues not sem as well as

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Todd and Eddie from the Icu Ed in

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Podcast.

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So we have discussed pragmatic trial design on

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prior episodes. And we definitely encourage. I was

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listening today if we haven't listened, definitely checked

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those out.

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John, but wondering maybe you could tell us

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a little bit more about what patients were

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included in this study

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as well as any, like, inclusion exclusion gray

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period and the outcomes and safety points that

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you would looked at.

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Yeah. Great. Maybe I'll start with the eligibility

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criteria and, like Kevin take any any outcomes,

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but the eligibility criteria or intended to be

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broad. So we're trying in these pragmatic trials

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to enroll a maximally general

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population. So we try to minimize an exclusion

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criteria

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to those that are really framed around safety.

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So or federal regulations. So have every patient

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undergoing oral trachea intubation with

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Intubation in an Edi Icu participating in the

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trial was eligible to everybody. The only people

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who were excluded were those who were children,

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known to be pregnant or prisoners,

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patients who are apt and required immediate

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ventilation in the pre action period

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or patients for whom the clinicians felt that

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either a non or read or non invasive

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ventilation was required or contra.

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Thanks, John. And then before we move and

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talk about the specifics of the methods could

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either of to Kevin and just tell us

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about as you were designing it, the primary

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outcomes you came up with. And then some

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of the cool secondary exploratory outcomes where you're

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looking at different levels of hypo of just

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set the framework for everywhere. I can certainly

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talk about the primary outcome and I'll. I'll

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let John take the secondary explored trade once.

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The primary outcome for this trial what was

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hypo hypoxia See is defined as oxygen saturation

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of less than 85 percent. We chose that

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value for a number of specific reasons. See

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First is that's on the steep port, part

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of the option this dis association curve. So

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patients with the saturation of 85 are very

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steep bun lipid saturation. Curve and are gonna

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rapidly them saturated further.

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Additionally, that's a value that has been associated

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with worse outcomes for patients that are going

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to intubation.

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Finally, from procedural standpoint to that's roughly

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the recommended point where,

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intubation attempts are aborted and re is initiated.

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From an outcome design standpoint, we had a

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real choice whether a binary outcome, which is

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to the person to saturated yes or no,

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or continuous variable outcome of what was the

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lowest option saturation. And I I think we

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ended up making the right choice of going

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with the binary

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outcome. It really tells the story more clearly.

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We actually included lowest

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saturation as the secondary outcome,

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00:10:19,367 --> 00:10:20,896
moves in the same direction as the primary,

265
00:10:21,055 --> 00:10:22,801
but I think the mess is stronger with

266
00:10:22,801 --> 00:10:25,103
the binary outcome. John's right than you wanna

267
00:10:25,103 --> 00:10:25,261
add.

268
00:10:26,214 --> 00:10:28,612
Yeah. Kelly mentioned this was... This is a

269
00:10:28,612 --> 00:10:30,683
very trial wonky case discussion, but people listen

270
00:10:30,683 --> 00:10:32,276
to this podcast or probably interested those kinds

271
00:10:32,276 --> 00:10:33,572
of decisions. And

272
00:10:34,108 --> 00:10:36,338
if people have followed our work, the prevent

273
00:10:36,338 --> 00:10:38,190
trial, which is also... Relevant. Here we might

274
00:10:38,190 --> 00:10:40,029
talk about later. Was a trial where the

275
00:10:40,029 --> 00:10:42,830
primary outcome was lowest oxygen saturation is continuous

276
00:10:42,830 --> 00:10:45,230
hear what was the absolute lowest oxygen saturation.

277
00:10:45,470 --> 00:10:46,756
To I think we learned a lot of

278
00:10:46,756 --> 00:10:48,821
things both in the analysis of that trial

279
00:10:48,821 --> 00:10:50,806
and in the reception, it received. What of

280
00:10:50,806 --> 00:10:53,109
what she is that, we... In that trial

281
00:10:53,109 --> 00:10:55,995
looked at both. Lowest option saturation is continuous

282
00:10:55,995 --> 00:10:58,629
and a binary variable, and people weren't as

283
00:10:58,629 --> 00:11:00,704
impressed by the continuous variable. So you can

284
00:11:00,704 --> 00:11:02,380
imagine that most people don't saturate,

285
00:11:02,873 --> 00:11:05,014
and that when you're looking at a device,

286
00:11:05,173 --> 00:11:08,029
it might change the the median action saturation

287
00:11:08,029 --> 00:11:11,058
for all patients from 99 to 96, or

288
00:11:11,058 --> 00:11:13,200
it might prevent extreme cases or hopefully it

289
00:11:13,200 --> 00:11:13,596
does both.

290
00:11:14,231 --> 00:11:16,769
But although the continuous outcome might be more

291
00:11:16,769 --> 00:11:17,666
statistically powerful

292
00:11:18,134 --> 00:11:20,760
If you change the median action saturation from

293
00:11:20,760 --> 00:11:23,467
96 percent to 90 99 percent, that alone

294
00:11:23,467 --> 00:11:25,616
is not very impressive or persuasive to people.

295
00:11:26,108 --> 00:11:27,719
So although you might be sacrificing

296
00:11:28,250 --> 00:11:30,710
statistical power going to a binary variable, that's

297
00:11:30,710 --> 00:11:32,932
the variable that we clearly receive feedback was,

298
00:11:33,423 --> 00:11:36,307
relevant to clinicians was preventing this d icon

299
00:11:36,443 --> 00:11:38,350
outcome that they are worried about their patients

300
00:11:38,350 --> 00:11:39,542
and that's more clinically relevant.

301
00:11:40,098 --> 00:11:41,948
Now, you've decided to go binary your outcome,

302
00:11:42,108 --> 00:11:43,626
you have to decide what threshold to choose.

303
00:11:44,026 --> 00:11:45,644
So there's never been a pre specified

304
00:11:46,023 --> 00:11:46,523
threshold

305
00:11:47,142 --> 00:11:48,341
that defines hypo,

306
00:11:48,740 --> 00:11:51,065
We can look at... Oxygen dis association curves

307
00:11:51,065 --> 00:11:53,292
to say, when does the risk start? And

308
00:11:53,292 --> 00:11:55,042
that's where we look to to pick the

309
00:11:55,042 --> 00:11:57,440
85 percent in this trial, But it's clearly

310
00:11:57,440 --> 00:11:59,423
true that there are many times like Bro

311
00:11:59,423 --> 00:12:02,144
h when our patients have moment maturity saturation

312
00:12:02,279 --> 00:12:04,024
and recover without any ill effects.

313
00:12:05,075 --> 00:12:06,754
I think our thought in this is some

314
00:12:06,754 --> 00:12:06,995
patients.

315
00:12:07,634 --> 00:12:10,355
Unfortunately, when they have low oxygen saturation, don't

316
00:12:10,355 --> 00:12:12,434
tolerate that and have cardiac arrest, but what

317
00:12:12,434 --> 00:12:14,863
threshold? Should you choose for that to prevent

318
00:12:15,636 --> 00:12:17,786
to... As the important threshold to prevent? So

319
00:12:17,786 --> 00:12:20,175
we chose 85 percent as the primary outcome

320
00:12:20,175 --> 00:12:21,863
and then as you mentioned, look, that other

321
00:12:21,863 --> 00:12:25,453
more severe thresholds has secondary exploratory outcome like

322
00:12:25,453 --> 00:12:27,288
oxygen saturation less than 80 percent and less

323
00:12:27,288 --> 00:12:28,779
than 70 percent. That

324
00:12:29,614 --> 00:12:32,317
Yeah. It's really interesting conversation. And I also

325
00:12:32,317 --> 00:12:34,543
feel like the... Having the binary, at least

326
00:12:34,543 --> 00:12:35,815
for me as a reader on it. I

327
00:12:35,815 --> 00:12:37,405
mean, this is already It's a pragmatic trial,

328
00:12:37,564 --> 00:12:40,361
so it's... A super applicable to, you know,

329
00:12:40,520 --> 00:12:43,461
our broad practice and having that binary is

330
00:12:43,461 --> 00:12:45,926
almost feels more applicable too because if you're

331
00:12:45,926 --> 00:12:47,730
they are in innovating and you have your

332
00:12:47,849 --> 00:12:49,995
little Qrs volume and it starts to go

333
00:12:49,995 --> 00:12:51,983
down. It's not like I'm not worried at

334
00:12:51,983 --> 00:12:54,288
85 and I worry at 82. Like I

335
00:12:54,288 --> 00:12:55,957
really worry about the fact that we're having

336
00:12:55,957 --> 00:12:58,201
that downtrend. And so in in some way

337
00:12:58,201 --> 00:12:59,794
as a reader of it, it makes it

338
00:13:00,352 --> 00:13:01,866
very applicable to say, oh, these are the

339
00:13:01,866 --> 00:13:04,415
number of patients we're having it. In lymph

340
00:13:04,415 --> 00:13:06,567
a trial like this, obviously, the specifics of

341
00:13:06,567 --> 00:13:08,568
what you guys did in your intervention can

342
00:13:08,568 --> 00:13:11,583
very much inform what the ongoing side practices.

343
00:13:11,821 --> 00:13:13,408
Kevin, I was hoping you could tell us

344
00:13:13,408 --> 00:13:16,202
in more detail what both p did nation

345
00:13:16,202 --> 00:13:18,904
methods were in each arm of the trial.

346
00:13:20,176 --> 00:13:22,004
Yes. We had 2 groups. We had a

347
00:13:22,004 --> 00:13:24,547
non invasive group in an auction mask group.

348
00:13:25,199 --> 00:13:28,070
In both groups, we recommended a minimum of

349
00:13:28,070 --> 00:13:29,527
3 minutes of pre.

350
00:13:29,905 --> 00:13:33,196
Now if the patient's condition warrant more media

351
00:13:33,334 --> 00:13:34,531
intubation, the operators could.

352
00:13:35,104 --> 00:13:36,930
But our goal is provide at least 3

353
00:13:36,930 --> 00:13:37,803
minutes per issue.

354
00:13:38,597 --> 00:13:40,662
In the non invasive group, we recommended where

355
00:13:40,662 --> 00:13:41,956
we required a minimum

356
00:13:42,409 --> 00:13:45,388
extra pressure of 05:10 water, but a minimum

357
00:13:45,765 --> 00:13:48,318
inventory pressure of Ken centimeters water and a

358
00:13:48,318 --> 00:13:50,790
set respiratory rate of 10 breast per, as

359
00:13:50,790 --> 00:13:52,327
well as delivering 100

360
00:13:52,465 --> 00:13:54,220
percent auction during the fractionation period.

361
00:13:55,271 --> 00:13:57,741
We encouraged clinicians to keep the non invasive

362
00:13:57,741 --> 00:14:00,928
ventilator on after induction of anesthesia until initiation

363
00:14:00,928 --> 00:14:01,486
wearing gossip.

364
00:14:02,376 --> 00:14:03,409
In the auction mask group,

365
00:14:04,521 --> 00:14:06,507
clinicians could use either a non or reader

366
00:14:06,507 --> 00:14:09,129
or bag mask device without positive pressure ventilation

367
00:14:09,129 --> 00:14:10,003
during pre oxygenation.

368
00:14:10,813 --> 00:14:13,682
We recommended the maximum lower rate possible, but

369
00:14:13,682 --> 00:14:15,435
we encourage people to give that least stick

370
00:14:15,435 --> 00:14:18,279
loot per minute, and we encourage continuation of

371
00:14:18,639 --> 00:14:21,133
auction between induction and initiate your.

372
00:14:21,990 --> 00:14:22,787
In both groups,

373
00:14:23,585 --> 00:14:25,715
clinicians could keep on nasal cannula of all

374
00:14:25,914 --> 00:14:28,307
forms including standard board companion as well as

375
00:14:28,307 --> 00:14:29,583
heat hypo blockage cannula.

376
00:14:30,859 --> 00:14:32,875
That's great. And on a very

377
00:14:33,411 --> 00:14:34,470
specific logistical

378
00:14:35,086 --> 00:14:38,275
standpoint, I'm curious how often if you guys

379
00:14:38,275 --> 00:14:40,019
know in the trial or in your own

380
00:14:40,019 --> 00:14:41,842
practice from being part of the trial that

381
00:14:41,842 --> 00:14:44,158
the non invasive device you... Using was the

382
00:14:44,158 --> 00:14:46,701
same device that then became the ventilator or

383
00:14:46,701 --> 00:14:48,371
if you guys had 2 devices in the

384
00:14:48,371 --> 00:14:49,427
room, which obviously

385
00:14:49,960 --> 00:14:52,186
compose some logistical hurdles while you're doing this.

386
00:14:52,345 --> 00:14:54,514
So in the Ico. That's a great question.

387
00:14:54,993 --> 00:14:56,828
The our hope during the implementation phase is

388
00:14:56,828 --> 00:14:58,264
that people will use this with the equipment

389
00:14:58,264 --> 00:15:00,351
that's already available in the room, In the

390
00:15:00,351 --> 00:15:02,099
trial, we gave sight the option to do

391
00:15:02,099 --> 00:15:04,959
either 1 and about a third of patients

392
00:15:04,959 --> 00:15:06,707
were activated at a site that used the

393
00:15:06,707 --> 00:15:08,217
invade the ventilator about 2 thirds.

394
00:15:08,868 --> 00:15:11,019
At sites that use the dedicated bypass machine.

395
00:15:11,576 --> 00:15:14,841
So, obviously, physiological, those 2 devices are equivalent

396
00:15:15,001 --> 00:15:17,333
Just how you wanna train your providers

397
00:15:17,644 --> 00:15:19,318
And I think the idea that people are

398
00:15:19,318 --> 00:15:21,152
gonna bring an dedicated a machine for 3

399
00:15:21,152 --> 00:15:24,043
minutes is even for a intervention that's pretty

400
00:15:24,101 --> 00:15:26,983
beneficial is probably too big ass. So certainly

401
00:15:26,983 --> 00:15:28,652
here the way we're training our staff and

402
00:15:28,652 --> 00:15:30,343
the way that we're asking all the network

403
00:15:30,638 --> 00:15:32,941
sites to train their staff during implementation phase.

404
00:15:33,433 --> 00:15:35,024
Is to make sure they have the equipment

405
00:15:35,024 --> 00:15:36,535
and training if to use the same ventilator

406
00:15:36,535 --> 00:15:38,284
that's already in the rib. We have the

407
00:15:38,284 --> 00:15:40,534
portion experience that re underwent the

408
00:15:41,147 --> 00:15:41,600
recall

409
00:15:42,195 --> 00:15:44,283
right? When we were starting with trial. So

410
00:15:44,498 --> 00:15:46,006
when we were launching of a trial, we

411
00:15:46,006 --> 00:15:48,333
had no dedicated by pet machines, would clearly

412
00:15:48,468 --> 00:15:49,421
the mechanical nightmares.

413
00:15:49,913 --> 00:15:52,163
Out, and that was actually quite helpful for

414
00:15:52,220 --> 00:15:54,686
changing institutional culture. So for the first 2

415
00:15:54,686 --> 00:15:57,329
thirds of the trial we exclusively use. E

416
00:15:57,329 --> 00:16:00,605
and then mechanical ball or pre fractionation. And

417
00:16:00,764 --> 00:16:02,362
I think it's the right answer. It it's

418
00:16:02,362 --> 00:16:04,280
most cost effective and it's very convenient.

419
00:16:04,934 --> 00:16:07,326
Yeah. Absolutely. Yeah. I think that it just

420
00:16:07,326 --> 00:16:09,240
would help... If that's the training, then nobody

421
00:16:09,240 --> 00:16:10,596
is like, oh, I don't wanna go get

422
00:16:10,596 --> 00:16:12,191
this other device and it just makes the

423
00:16:12,191 --> 00:16:14,759
hurdle so much lower. Oh, thanks for... Elaborated

424
00:16:14,759 --> 00:16:16,117
on that. And what we did at our

425
00:16:16,117 --> 00:16:17,556
site, and what I hope other sites do

426
00:16:17,556 --> 00:16:19,074
is, some ventilators,

427
00:16:19,633 --> 00:16:22,031
some hospital stock ventilators that can always do

428
00:16:22,031 --> 00:16:23,963
this. Our hospital stocks 2 types of ventilators,

429
00:16:24,122 --> 00:16:25,958
1 that has an ana modem and 1

430
00:16:25,958 --> 00:16:28,513
that doesn't. So we would preferential have 1

431
00:16:28,513 --> 00:16:31,227
ventilator ready for action so that could provide

432
00:16:31,227 --> 00:16:33,394
non have a mask just hanging on them,

433
00:16:33,712 --> 00:16:35,223
and that's the next 1 they pull when

434
00:16:35,223 --> 00:16:37,370
they're patient, they... And they pre auction it

435
00:16:37,370 --> 00:16:39,676
using that device, and then, use that vice

436
00:16:39,676 --> 00:16:40,733
for invasive mechanical

437
00:16:41,044 --> 00:16:42,319
later and then always make sure that there's

438
00:16:42,319 --> 00:16:43,912
1 in the equipment room setup for the

439
00:16:43,912 --> 00:16:44,811
next patient to be.

440
00:16:45,586 --> 00:16:45,984
That's great.

441
00:16:47,737 --> 00:16:48,215
And...

442
00:16:48,549 --> 00:16:50,145
Have another quick question as I'm thinking about

443
00:16:50,145 --> 00:16:51,821
this. I know John and Kevin you're at

444
00:16:51,821 --> 00:16:54,216
different institutions. Right? And I think that with

445
00:16:54,216 --> 00:16:57,262
this trial, different institutional practices that... Some of

446
00:16:57,262 --> 00:16:59,753
the team members who help with the

447
00:17:00,288 --> 00:17:00,788
Endo

448
00:17:01,243 --> 00:17:03,552
intubation may have been a bit surprised. Great

449
00:17:03,552 --> 00:17:05,720
you usually just reached for the the am

450
00:17:05,720 --> 00:17:07,799
bag and bad mask valve and some people

451
00:17:07,799 --> 00:17:08,920
maybe have walked in and be like what's

452
00:17:08,920 --> 00:17:10,700
going on? But how many others

453
00:17:11,080 --> 00:17:12,619
perceive this and were there any

454
00:17:13,000 --> 00:17:13,500
unexpected

455
00:17:14,293 --> 00:17:15,330
reactions that your head.

456
00:17:16,367 --> 00:17:18,680
So at least locally and I think in

457
00:17:18,680 --> 00:17:18,920
most,

458
00:17:19,718 --> 00:17:22,442
respiratory therapist search. Key partners in these intubation

459
00:17:22,442 --> 00:17:24,353
procedure. I I rely very heavily on them.

460
00:17:24,831 --> 00:17:26,344
I think most people doing so. They're are

461
00:17:26,344 --> 00:17:28,414
the people who are responsible for setting up

462
00:17:28,414 --> 00:17:31,060
the trachea tube. Yeah. They they provide the

463
00:17:31,060 --> 00:17:33,055
back mask ventilation in my institution. It was

464
00:17:33,055 --> 00:17:35,927
really important to get respiratory therapy buying in

465
00:17:35,927 --> 00:17:38,337
at the start. Yeah I think we mostly

466
00:17:38,337 --> 00:17:40,095
jeep bet. I do think that the rest

467
00:17:40,095 --> 00:17:43,371
therapist were appropriately skeptical about a relatively novel

468
00:17:43,371 --> 00:17:45,781
of intervention for them. So all practice was

469
00:17:45,781 --> 00:17:48,095
not to pre actually with non invasive prior

470
00:17:48,095 --> 00:17:50,090
to this study. So we had very limited

471
00:17:50,090 --> 00:17:52,085
experience with that. I think once they got...

472
00:17:52,259 --> 00:17:53,612
Familiar with it and now that they seen

473
00:17:53,612 --> 00:17:56,635
the outcomes, they're on onboard. It just... They

474
00:17:56,635 --> 00:17:58,864
had the appropriate skepticism that of about shame

475
00:17:58,864 --> 00:17:59,602
and their practice

476
00:18:00,315 --> 00:18:01,914
And I think they're right in having that.

477
00:18:03,115 --> 00:18:04,954
And I'll say it's it's all about expectations.

478
00:18:05,115 --> 00:18:06,714
So I think our site was also a

479
00:18:06,714 --> 00:18:08,646
site that didn't routinely do this. We have

480
00:18:08,646 --> 00:18:10,155
a lot of patients who are already on

481
00:18:10,155 --> 00:18:11,981
bi and would remain on bi path for

482
00:18:11,981 --> 00:18:15,316
pre fractionation. There are sites that were already

483
00:18:15,316 --> 00:18:17,080
routinely doing this and that certainly particularly common

484
00:18:17,080 --> 00:18:20,106
at international site like France and Australia that

485
00:18:20,106 --> 00:18:22,255
really routinely do this using the same ventilator

486
00:18:22,255 --> 00:18:24,460
that they'll use for invasive capital ventilation. It's

487
00:18:24,579 --> 00:18:26,090
And once we explain that to our Rt

488
00:18:26,090 --> 00:18:27,760
ortiz and really educate them on why we

489
00:18:27,760 --> 00:18:29,191
wanna do this trial and why this might

490
00:18:29,191 --> 00:18:31,895
be worthwhile. They bought in, so my experience

491
00:18:31,895 --> 00:18:33,983
in our Icu is, Walk in the room

492
00:18:33,983 --> 00:18:35,741
thinking I would require a lot of instruction

493
00:18:35,741 --> 00:18:38,059
or help, and it was already going. The

494
00:18:38,059 --> 00:18:39,657
fellow had already enrolled the patient and the

495
00:18:39,737 --> 00:18:41,256
Rt had already set up the mask was

496
00:18:41,256 --> 00:18:43,589
already correction on on eva before I walked

497
00:18:43,589 --> 00:18:45,269
in the room, and I hope that other

498
00:18:45,269 --> 00:18:48,230
sites similarly find that if you incorporate this

499
00:18:48,230 --> 00:18:49,269
into your usual practice,

500
00:18:49,843 --> 00:18:51,114
that there are a lot... There are a

501
00:18:51,114 --> 00:18:52,861
lot of things during the individual setup that

502
00:18:52,861 --> 00:18:55,641
require more time and energy than does placing

503
00:18:55,641 --> 00:18:57,468
a patient on invasive ventilation, and it was

504
00:18:57,468 --> 00:18:59,269
very easy to do that for 3 minutes

505
00:18:59,389 --> 00:19:01,147
during the setup for other park the procedure.

506
00:19:03,224 --> 00:19:04,902
Such a great point. Well thank he for

507
00:19:04,902 --> 00:19:07,467
sharing your perspective on that. And so you

508
00:19:07,467 --> 00:19:09,530
said pragmatic trial design enrolling,

509
00:19:10,085 --> 00:19:12,783
adults 18 years old and older, But wanted

510
00:19:12,783 --> 00:19:14,290
to hear Kevin from you a little bit

511
00:19:14,290 --> 00:19:16,299
more about... The group of patients that ended

512
00:19:16,299 --> 00:19:18,619
up being recruited as well as the randomization.

513
00:19:19,339 --> 00:19:21,099
Is there anything you wanna highlight about the

514
00:19:21,099 --> 00:19:23,339
cohorts or the intubation procedures itself?

515
00:19:24,152 --> 00:19:26,139
Yeah. I think what... I wanna just talk

516
00:19:26,139 --> 00:19:28,840
briefly about the background. So all prior trials

517
00:19:28,840 --> 00:19:30,906
in this space were limited to the Icu.

518
00:19:31,319 --> 00:19:33,228
At only patients with a acute hypoxia and

519
00:19:33,228 --> 00:19:35,057
respiratory go. They were small trials and they

520
00:19:35,057 --> 00:19:35,853
were not def definitive.

521
00:19:36,887 --> 00:19:39,530
What P did was we enrolled in both

522
00:19:39,530 --> 00:19:41,364
emergency departments and Icu.

523
00:19:41,923 --> 00:19:44,075
And as John alluded to... We had very

524
00:19:44,075 --> 00:19:46,627
broad eligibility criteria here. So we were enrolling

525
00:19:46,627 --> 00:19:49,114
any patient who critical and need to be

526
00:19:49,114 --> 00:19:50,571
today not just with the Q

527
00:19:51,107 --> 00:19:51,267
failure.

528
00:19:51,984 --> 00:19:53,499
The cohorts turned up to be very sick.

529
00:19:53,739 --> 00:19:55,333
Roughly 70 percent were in the Ic icu

530
00:19:55,333 --> 00:19:57,585
with time of intubation, A quarter were on

531
00:19:57,664 --> 00:20:00,704
High key prior intubation, a quarter were on

532
00:20:00,704 --> 00:20:03,424
vas at the time of intubation. The most

533
00:20:03,424 --> 00:20:06,065
common medical condition active during intubation was altered

534
00:20:06,065 --> 00:20:08,562
male. Sense. But the groups were similar, just

535
00:20:09,092 --> 00:20:11,945
very ill, very rod creek populations.

536
00:20:13,704 --> 00:20:15,384
1 part of the question, you might be

537
00:20:15,384 --> 00:20:18,664
asking is this population representative of, who we

538
00:20:18,664 --> 00:20:20,664
anticipate and did they exclude high risk respiration?

539
00:20:20,904 --> 00:20:22,674
I think that's always something about as you

540
00:20:22,674 --> 00:20:24,737
look at the concert diagram. Kevin correct can

541
00:20:24,737 --> 00:20:26,483
correct me on the number, but something like

542
00:20:26,483 --> 00:20:29,339
20 percent of discrete patients were excluded for

543
00:20:29,339 --> 00:20:30,053
urgency of intubation,

544
00:20:30,704 --> 00:20:32,538
And that's not... I think this something that

545
00:20:32,538 --> 00:20:34,691
takes time to set up, We worry how

546
00:20:34,691 --> 00:20:36,924
what proportion patients will be excluded for urgency?

547
00:20:37,403 --> 00:20:38,998
And is there gonna be a large group

548
00:20:38,998 --> 00:20:41,720
of patients that You can't deliver this intervention

549
00:20:41,720 --> 00:20:43,789
in. And thankfully, we found that no the

550
00:20:43,789 --> 00:20:45,562
mass majority of patients, even

551
00:20:46,175 --> 00:20:48,642
emergent intubation, they could place the non invasive

552
00:20:48,642 --> 00:20:51,529
machine And that exclusion rates not dissimilar to

553
00:20:51,529 --> 00:20:53,286
the exclusion rate we've seen in other interventions

554
00:20:53,286 --> 00:20:54,722
that take no time to set up like

555
00:20:54,722 --> 00:20:57,756
our recently completed device trial, video versus direct

556
00:20:57,756 --> 00:20:58,235
endoscopy,

557
00:20:58,649 --> 00:21:00,244
you wouldn't expect a lot of patients to

558
00:21:00,244 --> 00:21:02,636
be excluded for urgency in that trial because

559
00:21:02,636 --> 00:21:04,471
it takes some time to get trial material

560
00:21:04,471 --> 00:21:06,305
to begin an envelope to find someone to

561
00:21:06,305 --> 00:21:09,189
record, even for a A device that doesn't

562
00:21:09,189 --> 00:21:10,702
require a set of time, you guys still

563
00:21:10,702 --> 00:21:12,773
be excluded from the trial because the trial

564
00:21:12,773 --> 00:21:15,959
procedures require time, and the proportion patients excluded

565
00:21:15,959 --> 00:21:18,200
device was not that somewhere from in pre.

566
00:21:18,359 --> 00:21:20,424
So it wasn't that the intervention took so

567
00:21:20,424 --> 00:21:21,695
much time to set up that we were

568
00:21:21,695 --> 00:21:23,998
missing emergent innovation, which had been a concern

569
00:21:23,998 --> 00:21:26,158
of ours going in. And I think thankfully

570
00:21:26,158 --> 00:21:28,146
didn't occur. I think another question is, did

571
00:21:28,146 --> 00:21:30,054
we exclude people who were at high risk

572
00:21:30,054 --> 00:21:32,439
of the safety outcome. So there were people

573
00:21:32,439 --> 00:21:35,079
who were excluded for active Ms assist for

574
00:21:35,079 --> 00:21:37,156
hem, and I think if people are actively

575
00:21:37,156 --> 00:21:39,313
vomiting, you really shouldn't replace him mask on

576
00:21:39,313 --> 00:21:41,684
them. But the trial did enroll really peep

577
00:21:42,044 --> 00:21:43,482
large group people who are at high risk

578
00:21:43,482 --> 00:21:44,921
for aspiration, a lot of people with the

579
00:21:44,921 --> 00:21:47,877
active upper Gi bleeding, people who had recently

580
00:21:47,877 --> 00:21:48,117
taken,

581
00:21:48,756 --> 00:21:51,399
oral intake, So I think this trial, we

582
00:21:51,399 --> 00:21:53,467
believe enrolled the populations that we wanted to,

583
00:21:53,626 --> 00:21:54,978
which it is that people who were really

584
00:21:54,978 --> 00:21:57,443
sick, people who needed be integrated emergent and

585
00:21:57,443 --> 00:21:59,192
the people who were at risk for aspiration.

586
00:22:00,720 --> 00:22:02,791
Yeah. That's great. And thank you for pointing

587
00:22:02,791 --> 00:22:04,544
all those things out. Right? Because to your

588
00:22:04,544 --> 00:22:06,750
point is makes sense that if someone is

589
00:22:06,950 --> 00:22:09,349
actively having E opt you can't put a

590
00:22:09,349 --> 00:22:10,950
mask on them, but it doesn't mean that

591
00:22:10,950 --> 00:22:12,549
the patients you are used doing this in.

592
00:22:12,869 --> 00:22:14,630
We're not high risk for aspiration based on

593
00:22:14,630 --> 00:22:16,481
all the other risk that we know a

594
00:22:16,481 --> 00:22:18,634
c into innovation. Now that we have a

595
00:22:18,634 --> 00:22:20,309
good sense of what the trial was and

596
00:22:20,309 --> 00:22:21,585
who the patients who ended up in the

597
00:22:21,585 --> 00:22:23,658
trial are, John, can we walk us through

598
00:22:23,658 --> 00:22:24,296
what you guys found?

599
00:22:26,300 --> 00:22:28,446
Yeah. Happy to. So as a reminder, the

600
00:22:28,446 --> 00:22:29,320
primary outcome was,

601
00:22:29,956 --> 00:22:30,854
incidence of hypo

602
00:22:31,228 --> 00:22:33,294
identifies an oxygen saturation less than e 5

603
00:22:33,294 --> 00:22:36,430
percent between induction anesthesia in 2 minutes after

604
00:22:36,565 --> 00:22:39,263
intubation, and then occurred at 18.5

605
00:22:39,263 --> 00:22:41,089
percent of patients in the oxygen mass group

606
00:22:41,089 --> 00:22:42,359
of 118

607
00:22:42,359 --> 00:22:42,597
patients.

608
00:22:43,169 --> 00:22:45,730
And by comparison, it it occurred in 57

609
00:22:45,730 --> 00:22:48,609
patients, 9 quite 1 percent. So an absolute

610
00:22:48,609 --> 00:22:50,529
risk reduction of 9.4

611
00:22:50,529 --> 00:22:50,769
percent.

612
00:22:51,345 --> 00:22:53,184
And a p value of less than 0

613
00:22:53,184 --> 00:22:54,304
point 001

614
00:22:54,304 --> 00:22:56,304
and a relative risk reduction up greater than

615
00:22:56,304 --> 00:22:56,944
50 percent.

616
00:22:59,517 --> 00:23:01,988
Yeah. Pretty convincing and clear that we have,

617
00:23:02,786 --> 00:23:04,858
a reduction in the incidents that we're gonna

618
00:23:04,858 --> 00:23:06,315
have of hypo

619
00:23:06,692 --> 00:23:08,464
overall during this. And and I was hoping

620
00:23:08,464 --> 00:23:10,244
you could go a little bit more too

621
00:23:10,304 --> 00:23:12,164
into some of the severe hypo

622
00:23:12,464 --> 00:23:15,436
cardiac arrest, mostly because I think that... We

623
00:23:15,436 --> 00:23:17,901
know that having hypo during intubation is a

624
00:23:17,901 --> 00:23:20,309
risk factor for all these unto untold downstream

625
00:23:20,524 --> 00:23:22,274
outcomes. That being said, I think when you're

626
00:23:22,274 --> 00:23:24,196
reading this, what care about is how the

627
00:23:24,196 --> 00:23:26,340
patient did after the procedure and came through.

628
00:23:26,579 --> 00:23:28,167
And I'm curious what kind of signals you

629
00:23:28,167 --> 00:23:30,233
saw in those outcomes. Yeah. So as we've

630
00:23:30,233 --> 00:23:32,457
already talked about, this threshold of 85 percent,

631
00:23:32,949 --> 00:23:35,730
is somewhat arbitrary, so we have ph reasons

632
00:23:35,730 --> 00:23:36,207
for choosing

633
00:23:37,081 --> 00:23:39,306
recognize that you could told showed another thresholds.

634
00:23:39,783 --> 00:23:41,825
So we looked at other thresholds like as

635
00:23:42,263 --> 00:23:44,096
Oxygen saturation less than 80 percent and less

636
00:23:44,096 --> 00:23:46,327
than 70 percent, and we found basically the

637
00:23:46,327 --> 00:23:48,559
same signal every threshold. So at every threshold

638
00:23:48,559 --> 00:23:49,218
of high

639
00:23:49,849 --> 00:23:50,668
We reduced

640
00:23:51,045 --> 00:23:53,197
by more than half. And for example, the

641
00:23:53,197 --> 00:23:55,908
most severe cases oxygen saturation less than 70

642
00:23:55,908 --> 00:23:57,582
percent occurred in 5.7

643
00:23:57,582 --> 00:23:59,750
percent of patients, in the action mass group

644
00:23:59,750 --> 00:24:00,867
and 2.4

645
00:24:00,867 --> 00:24:03,817
percent in the non invasive ventilation group. And

646
00:24:03,817 --> 00:24:05,970
as you're alluding to, that the question is,

647
00:24:06,050 --> 00:24:07,405
does that matter for patients?

648
00:24:07,979 --> 00:24:09,972
So this has been an outcome that's been

649
00:24:09,972 --> 00:24:12,205
used in many prior trait intubation trials and

650
00:24:12,205 --> 00:24:14,677
that chosen as an outcome because it's closely

651
00:24:14,677 --> 00:24:16,964
linked in observational studies with

652
00:24:17,644 --> 00:24:18,845
the most worrisome outcome

653
00:24:19,565 --> 00:24:21,005
trach intubation cardiac arrest,

654
00:24:21,884 --> 00:24:23,265
but that doesn't prove

655
00:24:23,964 --> 00:24:26,776
preventing hyper will also prevent cardiac arrest. Maybe

656
00:24:26,776 --> 00:24:29,501
it's just that really sick patients experience hypo

657
00:24:29,795 --> 00:24:31,782
and the same patient experience cardiac arrest for

658
00:24:31,782 --> 00:24:32,338
other reasons.

659
00:24:32,894 --> 00:24:34,721
But I thought... In our prior trials,

660
00:24:35,372 --> 00:24:37,117
We've been reluctant to choose Cardiac arrest as

661
00:24:37,117 --> 00:24:39,180
an outcome because even though it occurs up

662
00:24:39,180 --> 00:24:40,846
to 3 percent of patients, it would require

663
00:24:40,846 --> 00:24:43,490
an extremely large trial tens of thousands of

664
00:24:43,490 --> 00:24:45,329
patients to be powered for that rare outcome.

665
00:24:46,130 --> 00:24:48,369
What we were pleasantly surprised to find in

666
00:24:48,369 --> 00:24:50,470
this trial is that by preventing hypo

667
00:24:51,104 --> 00:24:53,810
It appeared that we also prevented Cardiac arrest.

668
00:24:54,367 --> 00:24:57,312
The cardiac arrest occurred in 7 patients in

669
00:24:57,312 --> 00:24:58,880
the face mask oxygen group

670
00:24:59,400 --> 00:25:01,500
compared to 1 patient in the non invasive

671
00:25:01,559 --> 00:25:03,559
ventilation group, a difference that was significant with

672
00:25:03,559 --> 00:25:05,400
a p value of point 04I

673
00:25:05,400 --> 00:25:07,160
think that there's a couple of things. 1

674
00:25:07,160 --> 00:25:09,806
is it proves the importance of this outcome.

675
00:25:10,204 --> 00:25:11,638
But I think this is the first trial

676
00:25:11,638 --> 00:25:13,413
that now really shows that hypo

677
00:25:14,028 --> 00:25:16,498
is an important surrogate outcome during trait on

678
00:25:16,498 --> 00:25:18,367
the patient. And if you prevent hypo,

679
00:25:19,140 --> 00:25:21,687
you should prevent cardiac arrest and save lives.

680
00:25:22,642 --> 00:25:25,507
And further for this specific intervention, it shows

681
00:25:25,507 --> 00:25:28,306
that non invasive ventilation really has significant benefit,

682
00:25:28,466 --> 00:25:30,215
but not only does it prevent the outcome

683
00:25:30,215 --> 00:25:31,727
that we use clinicians cara.

684
00:25:32,283 --> 00:25:34,988
Hypo, it prevents an outcome that both clinicians

685
00:25:34,988 --> 00:25:36,753
and patients k a lot about, which is

686
00:25:36,753 --> 00:25:37,253
cardiac.

687
00:25:39,301 --> 00:25:41,871
Yeah. Definitely some very compelling evidence

688
00:25:42,326 --> 00:25:44,654
and outcomes there John and just to extend

689
00:25:44,654 --> 00:25:47,134
on 1 of the the outcomes kevin, and

690
00:25:47,134 --> 00:25:49,075
anything that you wanna add about the

691
00:25:49,454 --> 00:25:51,349
aspiration safety, comes in and we talked about

692
00:25:51,549 --> 00:25:53,702
that risk, a few times already during the

693
00:25:53,702 --> 00:25:55,138
show, but wanted to see if you wanted

694
00:25:55,138 --> 00:25:56,175
add think. That's right.

695
00:25:57,052 --> 00:25:58,967
I think I I think a lot what

696
00:25:58,967 --> 00:26:01,142
drives clinicians behavior is about in

697
00:26:01,454 --> 00:26:02,887
seizures fear of aspiration.

698
00:26:03,842 --> 00:26:05,138
We we don't know

699
00:26:05,594 --> 00:26:08,062
what's in patient's stomach at the time often

700
00:26:08,062 --> 00:26:09,358
that they are not fasting

701
00:26:09,669 --> 00:26:12,397
and that really guides stations both during the

702
00:26:12,613 --> 00:26:15,262
fractionation phase and also after induction

703
00:26:15,876 --> 00:26:17,467
that decision whether or not from the liver

704
00:26:17,467 --> 00:26:18,581
positive pressure ventilation.

705
00:26:19,553 --> 00:26:21,808
Really focused the design on trying to capture

706
00:26:22,185 --> 00:26:23,940
aspiration. So we we had a number of

707
00:26:23,940 --> 00:26:25,855
exploratory safety outcomes that we're focused on it.

708
00:26:26,428 --> 00:26:29,215
The first was operator reported aspiration. So I

709
00:26:29,215 --> 00:26:30,887
been the procedure the person doing the airway

710
00:26:30,887 --> 00:26:33,059
wrote down whether they the patient experienced

711
00:26:33,434 --> 00:26:34,231
aspiration during procedure.

712
00:26:34,964 --> 00:26:37,199
Additional safety outcomes were new infiltrate on chest

713
00:26:37,199 --> 00:26:38,316
and imaging after activation,

714
00:26:39,115 --> 00:26:41,988
oxygen saturation in 24 hours, and a fraction

715
00:26:41,988 --> 00:26:43,345
inspired auction at 24 hours.

716
00:26:43,996 --> 00:26:46,215
There was no statistical difference between any of

717
00:26:46,215 --> 00:26:47,880
the groups. Between the groups and any of

718
00:26:47,880 --> 00:26:50,519
those outcomes, suggesting that there was no risk

719
00:26:50,733 --> 00:26:53,292
aspiration. In fact, there are numerically few aspirations

720
00:26:53,292 --> 00:26:55,202
in the knowledge ventilation group and the option

721
00:26:55,202 --> 00:26:58,009
mass group. This is a really important binding

722
00:26:58,066 --> 00:26:58,359
because

723
00:26:58,875 --> 00:27:01,650
I think this should really encourage clinicians to

724
00:27:01,650 --> 00:27:04,503
reevaluate the risk benefit analysis of deposit pressure

725
00:27:04,503 --> 00:27:07,161
and fractionation, positive pressure. After ind

726
00:27:07,854 --> 00:27:08,968
and their decision making.

727
00:27:09,525 --> 00:27:11,116
I would point out that Doctor Casey is

728
00:27:11,116 --> 00:27:13,995
the first author of trial We've looked at

729
00:27:13,995 --> 00:27:17,020
positive pressure ventilation after induction, comparing bag mass

730
00:27:17,020 --> 00:27:20,125
ventilation into canonical rapidly within innovation. And they

731
00:27:20,125 --> 00:27:21,262
also found no

732
00:27:21,814 --> 00:27:23,432
between receipt deposit pressure

733
00:27:23,891 --> 00:27:24,690
ventilation and aspiration.

734
00:27:25,489 --> 00:27:28,465
Yeah. So for me, my takeaway is that

735
00:27:28,858 --> 00:27:31,801
Non invasive ventilation deposit pressure ventilation does not

736
00:27:31,801 --> 00:27:33,710
appear to be a substantial risk for aspiration

737
00:27:33,710 --> 00:27:34,346
during intubation.

738
00:27:35,062 --> 00:27:36,811
If the risk is there, it's very small

739
00:27:36,811 --> 00:27:39,617
answer literally outweighed by the benefits of preventing

740
00:27:39,617 --> 00:27:39,936
ty.

741
00:27:41,770 --> 00:27:43,205
And I think if I may, I'll just

742
00:27:43,205 --> 00:27:44,721
jump in and say that. I think 1

743
00:27:44,721 --> 00:27:47,048
question, this is a very strong held view

744
00:27:47,048 --> 00:27:48,801
by clinicians. So how do we get to

745
00:27:48,801 --> 00:27:51,293
the strong held view the positive pressure ventilation

746
00:27:51,430 --> 00:27:53,104
isn't safe after you,

747
00:27:53,741 --> 00:27:56,051
given a neuromuscular blocker and, it's been 1

748
00:27:56,051 --> 00:27:58,058
of the fun parts of research like this

749
00:27:58,058 --> 00:27:59,491
to dig into the data and say, where

750
00:27:59,491 --> 00:28:01,880
did that come from? And the answer is

751
00:28:01,880 --> 00:28:04,190
that the concern was raised in the 19

752
00:28:04,190 --> 00:28:06,358
fifties when we started doing trait home division

753
00:28:06,358 --> 00:28:07,157
for the first time.

754
00:28:07,797 --> 00:28:09,554
And the data that they gathered at that

755
00:28:09,554 --> 00:28:12,052
time was pretty poor, but they took healthy

756
00:28:12,111 --> 00:28:14,596
volunteers to the operating room and paralyzed them

757
00:28:14,596 --> 00:28:16,025
and said, how hard do we have to

758
00:28:16,025 --> 00:28:17,454
squeeze the bag before we can hear air

759
00:28:17,454 --> 00:28:18,089
on their stomach?

760
00:28:18,644 --> 00:28:20,152
And the answer wasn't even some of those

761
00:28:20,152 --> 00:28:22,296
studies that suggested that it never or rarely

762
00:28:22,296 --> 00:28:24,408
occur and some of those studies they establish

763
00:28:24,467 --> 00:28:27,184
threshold that it could occur... Might occur in

764
00:28:27,184 --> 00:28:29,021
normal banking, and that led to people saying,

765
00:28:29,181 --> 00:28:31,195
we we shouldn't do this. Those are pretty

766
00:28:31,195 --> 00:28:33,434
poor surrogate for what's happening in clinical care.

767
00:28:33,995 --> 00:28:35,934
And I think the other a

768
00:28:36,315 --> 00:28:37,455
relationship that has maybe

769
00:28:37,914 --> 00:28:38,735
convince people

770
00:28:39,368 --> 00:28:41,125
is that when do we bag people. So

771
00:28:41,125 --> 00:28:42,423
if we don't bag them prop.

772
00:28:42,801 --> 00:28:44,477
Only bag them when things are going poorly?

773
00:28:44,956 --> 00:28:47,032
And so what is it about, intubation where

774
00:28:47,032 --> 00:28:49,041
things are going poorly that leads to increased

775
00:28:49,041 --> 00:28:51,353
race rates of aspiration? Is it actually bag

776
00:28:51,353 --> 00:28:52,468
or is it the fact that we still

777
00:28:52,468 --> 00:28:53,983
have a learning scope and their throat at

778
00:28:53,983 --> 00:28:55,736
5 minutes when the s station might wearing

779
00:28:55,736 --> 00:28:57,687
off? I think people have these

780
00:28:58,225 --> 00:29:01,020
relationships that are perhaps not based very strong

781
00:29:01,020 --> 00:29:01,339
science.

782
00:29:01,898 --> 00:29:04,293
We now have 4 trials as Kevin mentioned,

783
00:29:04,532 --> 00:29:07,263
our prior prevent trial the cr trial and

784
00:29:07,263 --> 00:29:09,660
the 2 prior small trials and non the

785
00:29:09,660 --> 00:29:12,297
ventilation that Kevin mentioned from France that were

786
00:29:12,297 --> 00:29:14,703
conducted by By lord and group That and

787
00:29:14,703 --> 00:29:16,526
all 4 of those trials have looked at

788
00:29:16,526 --> 00:29:19,062
causing pressure ventilation after induction and have looked

789
00:29:19,062 --> 00:29:22,013
at aspiration as a primary safety outcome and

790
00:29:22,013 --> 00:29:23,688
none of those trial has there been any

791
00:29:23,688 --> 00:29:26,240
signal for increased activation. But I think that

792
00:29:26,240 --> 00:29:28,016
should be pre reassuring that

793
00:29:28,394 --> 00:29:28,894
during

794
00:29:29,271 --> 00:29:32,099
t intubation, a short period of approach fl

795
00:29:32,155 --> 00:29:34,800
positive pressure of ventilation at normal pressures

796
00:29:35,253 --> 00:29:37,636
doesn't increase the risk of aspiration, or even

797
00:29:37,636 --> 00:29:39,160
if it does, you could say these are

798
00:29:39,160 --> 00:29:41,461
rare events and altogether these trials have only

799
00:29:41,461 --> 00:29:44,078
enrolled several thousand patient. If there is any

800
00:29:44,078 --> 00:29:45,427
difference, very small,

801
00:29:45,998 --> 00:29:47,986
and the rate of that difference, it is

802
00:29:47,986 --> 00:29:49,894
dramatically smaller than the benefit from pipe... From

803
00:29:49,894 --> 00:29:52,438
hypo. Yeah. But I hope this trial and

804
00:29:52,438 --> 00:29:54,267
the body of evidence that building makes people

805
00:29:54,267 --> 00:29:56,055
really reevaluate those

806
00:29:56,355 --> 00:29:57,154
traditionally held beliefs.

807
00:29:58,115 --> 00:30:00,115
Yeah. And I wonder if the fact that

808
00:30:00,115 --> 00:30:01,715
you had some... The patients that you mentioned

809
00:30:01,715 --> 00:30:03,882
that were excluded just tells people that, yeah,

810
00:30:04,121 --> 00:30:06,268
You can, basically, based on your best clinical

811
00:30:06,268 --> 00:30:06,666
judgment,

812
00:30:07,382 --> 00:30:09,530
put yourself in this wrist. That's very low.

813
00:30:09,704 --> 00:30:12,184
You're basically excluding these extremely high risk patients,

814
00:30:12,424 --> 00:30:13,964
and these were just based on

815
00:30:14,664 --> 00:30:17,200
clinicians bedside clinical judgment. And so once you've

816
00:30:17,399 --> 00:30:18,992
taken them out, then you can feel really

817
00:30:18,992 --> 00:30:20,745
confident that you're not gonna have aspiration even

818
00:30:20,745 --> 00:30:22,817
though that there's this theoretical risk. Yeah. Can

819
00:30:22,896 --> 00:30:24,330
Push back a little bit on that? Please?

820
00:30:24,824 --> 00:30:26,343
Sure when we don't. Maybe we should cleared

821
00:30:26,343 --> 00:30:28,261
them. Next time me, there's so no aspiration

822
00:30:28,261 --> 00:30:30,898
or with joss, if Was was right. That

823
00:30:30,898 --> 00:30:32,576
someone who is vomit in their mouth should

824
00:30:32,576 --> 00:30:34,115
not be placed where Gonna be

825
00:30:34,428 --> 00:30:36,732
but I just don't think clinicians are that

826
00:30:36,732 --> 00:30:38,559
good at predicting outcomes. And so,

827
00:30:39,353 --> 00:30:40,807
I don't think we included

828
00:30:41,260 --> 00:30:42,713
high risk patients

829
00:30:43,024 --> 00:30:44,540
in a inappropriate or I don't think we

830
00:30:44,540 --> 00:30:46,853
were so good at at assessing risk for

831
00:30:46,853 --> 00:30:48,609
aspiration that we were able to identify those

832
00:30:48,609 --> 00:30:50,696
we're at high risk and exclude them. Or

833
00:30:50,696 --> 00:30:52,523
if we were, be the only condition work

834
00:30:52,523 --> 00:30:54,985
clinicians are that trick. And certainly, I'm not

835
00:30:54,985 --> 00:30:55,144
that.

836
00:30:56,177 --> 00:30:58,345
I just think that this is probably

837
00:30:58,719 --> 00:30:59,752
not a ph physiological.

838
00:31:00,719 --> 00:31:03,735
Relationship between positive pressure after induction as.

839
00:31:04,528 --> 00:31:06,433
K Kevin sensitive to that because the... This

840
00:31:06,433 --> 00:31:08,099
was the what the takeaway from the event

841
00:31:08,099 --> 00:31:10,182
trials but we similar findings the prevent trial,

842
00:31:10,261 --> 00:31:11,455
and if you go to update up to

843
00:31:11,455 --> 00:31:12,092
date today,

844
00:31:12,728 --> 00:31:15,116
they recommend that you should only back people

845
00:31:15,116 --> 00:31:16,867
who are high risk of the outcome and

846
00:31:16,867 --> 00:31:19,028
low risk for aspiration. And I disagree with

847
00:31:19,028 --> 00:31:20,140
that. That's not the way we did the

848
00:31:20,140 --> 00:31:22,362
trial. We tried to include everybody, and we

849
00:31:22,362 --> 00:31:24,346
allow always want to allow clinicians do with

850
00:31:24,346 --> 00:31:26,587
everything is right for their patients. And we

851
00:31:26,587 --> 00:31:27,944
agree that you shouldn't put a mask on

852
00:31:27,944 --> 00:31:29,779
people who are actively vomiting, and there may

853
00:31:29,779 --> 00:31:31,614
be some clinicians who participate in the trial

854
00:31:31,614 --> 00:31:33,505
who excluded people who are iris risk

855
00:31:33,863 --> 00:31:36,408
many clinicians include all other patients who weren't

856
00:31:36,408 --> 00:31:38,954
actively vomiting. Like myself, I didn't exclude a

857
00:31:38,954 --> 00:31:39,988
single patient for,

858
00:31:40,704 --> 00:31:43,910
risk of aspiration And those patients are well

859
00:31:43,910 --> 00:31:45,929
represented in this trial, and there's no evidence

860
00:31:45,990 --> 00:31:49,269
that there's any increased risk. But I think

861
00:31:49,269 --> 00:31:50,089
clinicians should

862
00:31:50,482 --> 00:31:52,707
think about how they operationalize this. I agree

863
00:31:52,707 --> 00:31:54,932
that a patient who's actively vomiting, maybe even

864
00:31:54,932 --> 00:31:56,759
1 who tick a, and looks shady. You

865
00:31:56,759 --> 00:31:58,507
might think about not place this mask on.

866
00:31:59,079 --> 00:32:00,826
But I think the vast majority of patients

867
00:32:00,826 --> 00:32:02,732
should be begin this intervention, and it's not

868
00:32:02,732 --> 00:32:04,400
as if you should be assessing risk factors

869
00:32:04,400 --> 00:32:06,862
for aspiration and then excluding patients from this

870
00:32:06,862 --> 00:32:08,311
intervention. That's not the way we did the

871
00:32:08,311 --> 00:32:10,383
trial, and that's not the the population I

872
00:32:10,383 --> 00:32:12,456
think this should apply to. That's great. Thank

873
00:32:12,456 --> 00:32:14,290
you for pointing. No. I appreciate the shooting

874
00:32:14,290 --> 00:32:16,139
feedback on. I think that's super helpful. Think

875
00:32:16,139 --> 00:32:17,578
about because when you're reading it, and then

876
00:32:17,578 --> 00:32:19,016
you're gonna take it to your bedside, then

877
00:32:19,016 --> 00:32:20,615
you can feel more confident. I love that.

878
00:32:21,094 --> 00:32:22,612
I I do have 1 more question too.

879
00:32:22,852 --> 00:32:24,610
And it's very... This made me a a

880
00:32:24,610 --> 00:32:25,464
difficult question

881
00:32:25,902 --> 00:32:28,050
about the data to analyze through the data.

882
00:32:28,368 --> 00:32:30,278
But I'm curious. I know that you guys

883
00:32:30,278 --> 00:32:32,108
have also done prior trials on first pass

884
00:32:32,108 --> 00:32:34,119
success and you need video versus direct lara.

885
00:32:34,748 --> 00:32:36,578
I'm curious if not that there was a

886
00:32:36,578 --> 00:32:38,407
difference between the 2 groups. I know from

887
00:32:38,407 --> 00:32:40,396
your supplement that they had good first pass

888
00:32:40,396 --> 00:32:42,643
success in both groups. If the patients who

889
00:32:42,643 --> 00:32:43,463
had hypo,

890
00:32:43,922 --> 00:32:45,221
especially that severe hypo

891
00:32:45,840 --> 00:32:49,356
had longer durations or more times or they

892
00:32:49,356 --> 00:32:51,287
didn't have first fast success I'm just thinking

893
00:32:51,287 --> 00:32:53,201
about my own experience, like, when that patient

894
00:32:53,201 --> 00:32:54,180
starts getting hypo.

895
00:32:54,557 --> 00:32:56,631
That's when everyone starts getting nervous. And that's

896
00:32:56,631 --> 00:32:58,625
when things kinda start getting a little more

897
00:32:58,625 --> 00:33:01,112
chaotic during the intubation procedure, and I'm curious

898
00:33:01,112 --> 00:33:02,707
if you guys saw any signal like that.

899
00:33:03,743 --> 00:33:05,975
So it's definitely true that when you fail

900
00:33:05,975 --> 00:33:07,968
on your first attempt, you at increased risk

901
00:33:07,968 --> 00:33:10,470
for all kinds of bad outcomes, including hypo.

902
00:33:11,716 --> 00:33:14,097
And so, and intervention like this might be

903
00:33:14,097 --> 00:33:16,970
more protective against cases like that. Challenge is,

904
00:33:17,129 --> 00:33:18,638
you don't know going in who you're gonna

905
00:33:18,638 --> 00:33:20,384
fail in. So that's what we call a

906
00:33:20,384 --> 00:33:22,528
post randomization variable. So we tend not to

907
00:33:22,528 --> 00:33:24,037
look at a lot of analysis like that.

908
00:33:24,846 --> 00:33:27,468
Because you should make decisions how you treat

909
00:33:27,468 --> 00:33:29,057
patients based on what's noble the time you

910
00:33:29,057 --> 00:33:30,804
have to make that decision, and I don't

911
00:33:30,804 --> 00:33:33,028
know when I'm on creation device if I'm

912
00:33:33,028 --> 00:33:35,192
gonna fail or not. By bet. I better

913
00:33:35,192 --> 00:33:36,468
do the thing that gives me the best

914
00:33:36,468 --> 00:33:37,984
chance whether or not I feel. So that's

915
00:33:37,984 --> 00:33:40,377
1 answer. The second is that we do

916
00:33:40,377 --> 00:33:42,542
look at this and say, are these outcomes

917
00:33:42,542 --> 00:33:44,927
occurring only in patients who had failure in

918
00:33:44,927 --> 00:33:46,835
the first attempt or not. And the answer

919
00:33:46,835 --> 00:33:48,424
is even though when you fail on the

920
00:33:48,424 --> 00:33:49,696
first attempt you have a higher risk of

921
00:33:49,696 --> 00:33:50,196
hypo,

922
00:33:50,903 --> 00:33:52,731
That's the minority of patients we succeed in

923
00:33:52,731 --> 00:33:55,196
the first attempt in 85 percent of patients.

924
00:33:55,514 --> 00:33:57,899
So most events of hypo are occurring in

925
00:33:57,899 --> 00:34:00,144
people who We successfully activate in the first

926
00:34:00,144 --> 00:34:01,897
town. So we did everything right with everything

927
00:34:01,897 --> 00:34:04,288
perfectly well. We had a short and successful

928
00:34:04,288 --> 00:34:06,440
debate and the patients still experience ty senior.

929
00:34:06,854 --> 00:34:09,166
And so those patients also benefit. But he

930
00:34:09,166 --> 00:34:10,602
this also comes up when you talk about

931
00:34:10,602 --> 00:34:13,393
operator experience. But this intervention may be even

932
00:34:13,393 --> 00:34:16,439
more beneficial for an periods operator who's like

933
00:34:16,439 --> 00:34:18,277
that it take longer to debate and expose

934
00:34:18,277 --> 00:34:19,955
their patient to a longer period of apnea,

935
00:34:20,355 --> 00:34:23,391
But it's also beneficial for already experienced operators

936
00:34:23,391 --> 00:34:24,830
who are likely to... Your patient in the

937
00:34:24,830 --> 00:34:25,310
first attempt.

938
00:34:26,923 --> 00:34:28,281
Yeah. It's so great. Night. I just was

939
00:34:28,281 --> 00:34:29,400
just thinking, I was like, there is not

940
00:34:29,400 --> 00:34:31,398
a little bit of pushback from Kevin Gibbs.

941
00:34:31,557 --> 00:34:33,635
Is is it really Kevin's. Thank you and

942
00:34:33,635 --> 00:34:35,563
just I think having us think of different

943
00:34:35,563 --> 00:34:36,041
perspectives.

944
00:34:36,679 --> 00:34:38,591
I think 1 other question of Fe and

945
00:34:38,671 --> 00:34:41,061
I were also just thinking about chew was

946
00:34:41,061 --> 00:34:44,505
disease of hypo cannula for pre oxygenation. It

947
00:34:44,505 --> 00:34:47,085
looks like there were some, people on hypo

948
00:34:47,144 --> 00:34:49,865
cannula prior to the intubation and then underwent

949
00:34:49,865 --> 00:34:51,244
intubation per a trial protocol

950
00:34:51,958 --> 00:34:53,633
we're both wondering if if you wanna share

951
00:34:53,633 --> 00:34:56,127
any thoughts of incorporating hypoglycemia nasal cannula

952
00:34:56,504 --> 00:34:59,296
and to trial methods in the future or

953
00:34:59,296 --> 00:35:00,572
anything that you wanna share about that?

954
00:35:01,465 --> 00:35:03,784
Yeah. I think consideration of pap leukemia is

955
00:35:03,784 --> 00:35:05,244
really important for text.

956
00:35:06,264 --> 00:35:08,744
First comment I had is that p does

957
00:35:08,744 --> 00:35:10,533
not inform the use of hypo

958
00:35:10,987 --> 00:35:13,849
for fractionation. It it was allowed in both

959
00:35:13,849 --> 00:35:14,088
groups.

960
00:35:14,724 --> 00:35:17,427
It occurred more commonly in the auction mask

961
00:35:17,427 --> 00:35:20,305
a non invasive group. Though, we specifically didn't

962
00:35:20,305 --> 00:35:22,396
analyzed whether that impact the rates eye

963
00:35:22,851 --> 00:35:23,089
study.

964
00:35:24,203 --> 00:35:25,237
On a personal level,

965
00:35:25,889 --> 00:35:28,681
I'm a little skeptical about using hypo cannula

966
00:35:28,681 --> 00:35:31,073
as a fractionation strategy. This has been studied,

967
00:35:31,233 --> 00:35:33,067
and the data is quite mixed. In some

968
00:35:33,067 --> 00:35:34,902
studies it's equivalent to non invasive in subsidies.

969
00:35:35,061 --> 00:35:37,230
It's not. And says some studies is not

970
00:35:37,230 --> 00:35:38,426
better than an auction mask.

971
00:35:39,383 --> 00:35:41,718
What what is true is that hypo

972
00:35:42,175 --> 00:35:43,233
is not provide

973
00:35:43,610 --> 00:35:46,494
positive pressure ventilation after induction vantage. And so

974
00:35:46,494 --> 00:35:48,722
all the benefits that you experienced with positive

975
00:35:48,722 --> 00:35:51,506
pressure after production do not are not delivered

976
00:35:51,506 --> 00:35:52,460
by hypo k.

977
00:35:53,512 --> 00:35:54,947
From a practical standpoint,

978
00:35:55,585 --> 00:35:57,977
many ventilators are capable delivering high nasal cable,

979
00:35:58,057 --> 00:36:00,768
but not all, and certainly, no ventilators are

980
00:36:00,768 --> 00:36:03,176
capable of delivering both non invasive ventilation and

981
00:36:03,176 --> 00:36:04,793
on high occasional simultaneously?

982
00:36:05,329 --> 00:36:07,483
So you're really confronted with a choice of

983
00:36:07,483 --> 00:36:09,636
which of these interventions are you going to

984
00:36:09,636 --> 00:36:11,550
use for your pre preoccupied strategy?

985
00:36:12,124 --> 00:36:14,040
From my standpoint, we have robust data that

986
00:36:14,040 --> 00:36:16,137
non invasive ventilation is

987
00:36:16,594 --> 00:36:17,813
superior auction masks

988
00:36:18,271 --> 00:36:20,665
and decreases the risk of cardiac arrest during

989
00:36:20,745 --> 00:36:22,598
Debate. And so that's the strategy that I

990
00:36:22,598 --> 00:36:24,356
would choose. I I don't think it's really

991
00:36:24,356 --> 00:36:26,354
practical to wheel in and the height occasionally

992
00:36:26,354 --> 00:36:28,272
and set that up and then for 3

993
00:36:28,272 --> 00:36:30,110
minutes while you're... While even you could disconnect

994
00:36:30,110 --> 00:36:30,724
the non

995
00:36:31,083 --> 00:36:33,789
layered machine. Not based mask machine and deliver

996
00:36:33,789 --> 00:36:36,018
not a stimulation. But John did additional opinions

997
00:36:36,018 --> 00:36:38,405
on there? Yeah. You could tell. This is

998
00:36:38,405 --> 00:36:39,679
something that we've talked to a lot about

999
00:36:39,679 --> 00:36:41,288
and thought a lot about the design phase

1000
00:36:41,288 --> 00:36:43,284
and even in the short time and published

1001
00:36:43,284 --> 00:36:45,359
it and asked a lot about. And just

1002
00:36:45,359 --> 00:36:47,355
to explain arc our kinda of rationale for

1003
00:36:47,355 --> 00:36:50,243
why it wasn't either mandated or it of

1004
00:36:50,243 --> 00:36:52,315
the control intervention or included a third arm.

1005
00:36:53,112 --> 00:36:54,785
The first is that it's not used very

1006
00:36:54,785 --> 00:36:57,175
commonly. So if you look at national

1007
00:36:58,052 --> 00:36:59,087
And you look at the data from Our

1008
00:36:59,087 --> 00:37:01,416
fire network In the tube study, for example,

1009
00:37:01,496 --> 00:37:04,210
which is the best international registry on treatment

1010
00:37:04,210 --> 00:37:04,928
intubation practices,

1011
00:37:05,327 --> 00:37:08,121
high cannula as patient only use 8 percent

1012
00:37:08,121 --> 00:37:10,772
of patient. So not being done very commonly

1013
00:37:10,772 --> 00:37:14,608
now, the advantage of P cannula, even over

1014
00:37:14,608 --> 00:37:17,380
a device like non invasive ventilation is that

1015
00:37:17,659 --> 00:37:19,900
During the time that you're performing trait on

1016
00:37:19,900 --> 00:37:22,460
intubation, the in the mouth, you can still

1017
00:37:22,460 --> 00:37:25,275
have this high cannula in place, and maybe

1018
00:37:25,275 --> 00:37:27,514
be delivering oxygen through diffusion even on the

1019
00:37:27,514 --> 00:37:29,054
patient's acne, they'll called ethnic

1020
00:37:29,355 --> 00:37:29,514
oxygenation,

1021
00:37:30,234 --> 00:37:32,569
That a potential benefit really cite a lot

1022
00:37:32,569 --> 00:37:34,887
of people and appears unfortunately to have been

1023
00:37:34,887 --> 00:37:36,325
overblown. So now there been a lot of

1024
00:37:36,325 --> 00:37:39,302
trials looking at ethnic oxygenation that have shown

1025
00:37:39,362 --> 00:37:40,880
no benefit or a small beta.

1026
00:37:41,533 --> 00:37:43,940
And trials that have looked at Hypo cannula

1027
00:37:43,996 --> 00:37:46,617
compared to face mask as Kevin mentioned have

1028
00:37:46,617 --> 00:37:48,762
have not shown a difference, maybe differences in

1029
00:37:48,762 --> 00:37:51,269
some subgroups like patients with severe hypo,

1030
00:37:51,730 --> 00:37:55,090
but no benefits overall. And then there's AAA

1031
00:37:55,090 --> 00:37:57,570
trial that directly compared hypo cannula on non

1032
00:37:57,570 --> 00:38:01,039
invasive ventilation, the the P Lead 2 trial

1033
00:38:01,414 --> 00:38:02,845
and that I hope to find a benefit

1034
00:38:02,845 --> 00:38:05,390
of high cannula and found that not only

1035
00:38:05,390 --> 00:38:07,162
was it not better than a non invasive

1036
00:38:07,219 --> 00:38:10,093
ventilation actually appeared superior in patients who high

1037
00:38:10,093 --> 00:38:12,317
risk. So looking at that body of evidence,

1038
00:38:12,475 --> 00:38:15,254
we felt... If you're gonna bring a special

1039
00:38:15,254 --> 00:38:16,365
device in the room. And I think it

1040
00:38:16,365 --> 00:38:18,525
is important to note that many ventilators can

1041
00:38:18,525 --> 00:38:20,831
and deliver either high flow or non invasive,

1042
00:38:21,069 --> 00:38:24,089
but not both, as Kevin mentioned. So if

1043
00:38:24,089 --> 00:38:25,997
you're gonna bring that device in the room,

1044
00:38:26,489 --> 00:38:28,747
You should probably bring in the the... And

1045
00:38:28,886 --> 00:38:31,123
you should bring the device that's most likely

1046
00:38:31,123 --> 00:38:32,880
to have benefit, and that's why we chose

1047
00:38:32,880 --> 00:38:35,612
to compare. Non invasive that the strategy that

1048
00:38:35,612 --> 00:38:38,249
had the best preliminary evidence against the strategy

1049
00:38:38,249 --> 00:38:40,108
that people were actually using, which is,

1050
00:38:40,567 --> 00:38:42,085
non re breeder or bang mask and fight.

1051
00:38:42,579 --> 00:38:44,577
I think High cannula is something that I

1052
00:38:44,577 --> 00:38:46,335
think people will continue to ask about and

1053
00:38:46,335 --> 00:38:48,092
maybe additional evidence will

1054
00:38:48,652 --> 00:38:51,543
accrue, but I I personally believe that preliminary

1055
00:38:51,543 --> 00:38:53,858
evidence, say just and that there's...

1056
00:38:55,134 --> 00:38:57,768
That it's not certainly not better than and

1057
00:38:57,768 --> 00:38:59,125
probably not as as not basis.

1058
00:38:59,935 --> 00:39:01,922
Thank you, of, Kevin and John for for

1059
00:39:01,922 --> 00:39:03,831
walking us through that, and you've already talked

1060
00:39:03,831 --> 00:39:05,762
and alluded to several of the main takeaways

1061
00:39:05,898 --> 00:39:06,851
from this trial.

1062
00:39:07,424 --> 00:39:09,739
And I haven't been... I haven't attended an

1063
00:39:09,978 --> 00:39:11,734
Icu since the results have come out. But

1064
00:39:11,734 --> 00:39:13,730
just a quick question. I'm just interested for,

1065
00:39:13,889 --> 00:39:15,246
I don't know if you have are Kevin

1066
00:39:15,246 --> 00:39:16,859
and John. How have how has your day

1067
00:39:16,859 --> 00:39:19,097
to day personal practice changed from these results?

1068
00:39:20,056 --> 00:39:22,133
For me, I I think the the most

1069
00:39:22,133 --> 00:39:24,211
striking thing about trial. Think that I I

1070
00:39:24,211 --> 00:39:25,590
was not prepared for

1071
00:39:25,983 --> 00:39:29,008
was that non invasive ventilation benefited all subgroups.

1072
00:39:29,326 --> 00:39:31,873
And even patients who were not hypo or

1073
00:39:31,873 --> 00:39:33,624
who I not classified for being at high

1074
00:39:33,624 --> 00:39:37,298
risk for saturation invasion? Had less hypo when

1075
00:39:37,298 --> 00:39:39,603
they received non invasive. So patients who on

1076
00:39:39,603 --> 00:39:41,750
room air who did not have a diagnosis

1077
00:39:41,750 --> 00:39:44,708
of respiratory failure at a lower incidence of

1078
00:39:44,708 --> 00:39:45,208
hypo

1079
00:39:45,982 --> 00:39:47,415
when they were p with non.

1080
00:39:47,893 --> 00:39:50,202
That's really powerful for me. We're we're reducing

1081
00:39:50,202 --> 00:39:52,608
the risk of bad outcomes even in patients

1082
00:39:52,608 --> 00:39:54,126
who were at low risk for high bias.

1083
00:39:54,925 --> 00:39:57,641
And so my practice assistant to adopt, adopt

1084
00:39:57,641 --> 00:39:58,360
this broadly.

1085
00:39:58,934 --> 00:40:01,970
Essentially any patient I innovating will receive non

1086
00:40:01,970 --> 00:40:02,929
invasive pre fractionation.

1087
00:40:04,367 --> 00:40:06,457
Yeah. I totally rude Kevin. I think if

1088
00:40:06,457 --> 00:40:07,809
you'd asked us in our heart of heart

1089
00:40:07,809 --> 00:40:09,401
says investigators what we would find.

1090
00:40:10,037 --> 00:40:11,470
I think there was a range of pins

1091
00:40:11,470 --> 00:40:13,618
within the group and we actually evaluated that

1092
00:40:13,618 --> 00:40:15,942
before we showed the the results. And there

1093
00:40:15,942 --> 00:40:17,617
were a fair number within the network who

1094
00:40:17,617 --> 00:40:19,053
didn't think it would be beneficial at all.

1095
00:40:19,611 --> 00:40:21,206
And there were others who thought, I would

1096
00:40:21,206 --> 00:40:22,882
say the majority opinion might have been that

1097
00:40:22,882 --> 00:40:24,796
would only be effective amongst those who were

1098
00:40:24,796 --> 00:40:27,210
high risk. And I think that's probably where

1099
00:40:27,769 --> 00:40:30,010
landon. I thought this was gonna work, but

1100
00:40:30,010 --> 00:40:32,409
the benefit was gonna be largely or all

1101
00:40:32,409 --> 00:40:34,304
in people who were high risk who were

1102
00:40:34,423 --> 00:40:36,967
already line of oxygen were be for respiratory

1103
00:40:36,967 --> 00:40:39,114
failure. And we found that the effect was

1104
00:40:39,114 --> 00:40:41,817
really consistent across all groups as Kevin mentioned,

1105
00:40:42,389 --> 00:40:44,730
even people who are being integrated for ultimate

1106
00:40:44,789 --> 00:40:47,510
status, even people who are on room air

1107
00:40:47,510 --> 00:40:48,710
with the time you made the decision it,

1108
00:40:49,030 --> 00:40:51,030
even amongst those people you cut in half

1109
00:40:51,030 --> 00:40:52,716
the risk of I see yet. But I

1110
00:40:52,716 --> 00:40:54,543
think that's really changed the way that we

1111
00:40:54,543 --> 00:40:56,847
have have approached the implementation of our own

1112
00:40:56,847 --> 00:40:59,627
site. As Dave mentioned, it takes effort. So

1113
00:40:59,627 --> 00:41:01,349
it we put a lot of effort in

1114
00:41:01,629 --> 00:41:03,064
during the trial to make sure we could

1115
00:41:03,064 --> 00:41:04,260
deliver this intervention well.

1116
00:41:04,818 --> 00:41:06,572
And then the trial ended, and,

1117
00:41:07,210 --> 00:41:08,566
we didn't know the results yet, and we

1118
00:41:08,566 --> 00:41:10,081
fell out of the habit. Nah.

1119
00:41:10,574 --> 00:41:12,641
Now that I'm back on, I asked for

1120
00:41:12,641 --> 00:41:14,630
it, and it has not... But I don't

1121
00:41:14,630 --> 00:41:16,221
ask it. It doesn't happen, and now we

1122
00:41:16,221 --> 00:41:17,175
are intentionally...

1123
00:41:17,748 --> 00:41:19,446
And now that the trial results are public

1124
00:41:19,584 --> 00:41:21,500
intentionally implementing this in a very systematic way.

1125
00:41:21,659 --> 00:41:24,293
So I hope that going forward, every patient

1126
00:41:24,293 --> 00:41:26,303
entity in my Icu will receive this, But

1127
00:41:26,303 --> 00:41:28,214
it's not gonna happen on own and gonna

1128
00:41:28,214 --> 00:41:30,603
happen through word mouth it's gonna take interfacing

1129
00:41:30,603 --> 00:41:32,913
with the Rt ortiz and a really intentional

1130
00:41:32,913 --> 00:41:34,187
approach to implementing the direction.

1131
00:41:35,400 --> 00:41:36,199
That's great great.

1132
00:41:36,920 --> 00:41:38,440
John, the only thing that I think that

1133
00:41:38,440 --> 00:41:39,960
you meant to say was instead of your

1134
00:41:39,960 --> 00:41:41,320
heart of heart, you met your lung of

1135
00:41:41,320 --> 00:41:43,079
longs. Right? Is where you're everyone. Felt like

1136
00:41:43,079 --> 00:41:45,349
this if you can have. You got I

1137
00:41:45,565 --> 00:41:47,712
Chris is an awesome was discussion though so

1138
00:41:47,712 --> 00:41:49,462
much for conductor the trial or for the

1139
00:41:49,462 --> 00:41:50,655
great work that you're doing, and then for

1140
00:41:50,655 --> 00:41:52,166
coming on the show to talk about it.

1141
00:41:52,498 --> 00:41:54,802
And we hope that everybody's enjoyed listening. If

1142
00:41:54,802 --> 00:41:56,549
you guys are listening now, please make sure

1143
00:41:56,549 --> 00:41:57,049
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1144
00:41:57,581 --> 00:42:00,043
subscribe, give us 5 stars. Wherever everywhere listening

1145
00:42:00,043 --> 00:42:01,711
and join us back in 2 weeks for

1146
00:42:01,711 --> 00:42:04,112
our episode. And this episode was rear edited

1147
00:42:04,112 --> 00:42:06,101
and produced by myself in Christina Mont, the

1148
00:42:06,101 --> 00:42:08,328
music's original music by Eric Rogers, and we'll

1149
00:42:08,328 --> 00:42:08,806
see you next time.