BreatheTV Episode 2
Dr. Michael McQueen | A Trip to Phoenix, Neonatal Clinical Trials, and Vapotherm in the NICU
Chris Walker: Hi everyone, welcome to the second episode of BreatheTV, where we sit down with clinicians, respiratory therapist and nurses to discuss the use of high flow nasal cannula and other respiratory support modalities.
Today we have Dr. Mike McQueen with us, today. And, really happy to sit down and spend some time, it’s been a little while since we connected last, so happy to be here in Phoenix, Arizona and I’d just like to give Mike the floor to introduce himself.
Dr. McQueen: Thank you Chris, it’s good to see you and thank you for the honor of including me in this. I’m glad you said clinicians because that’s probably the best answer to who I am. For 27 years I’ve been a Primary Practice Neonatologist. I’ve worked in multiple settings, for close to a decade I was the medical director of our local children’s hospital here in Arizona, Phoenix Children’s Hospital. Subsequent to that time I have branched out and done more community hospital work.
Currently the practice that I’m affiliated with is involved in seven community NICU’s here in Phoenix. Three of those, sorry, two of those are level three nurseries and five are level two nurseries. And again, I’ve been doing this about 27 years, and I’ve been using Vapotherm since about 2005, so I’m in my 12th year now of using it.
Chris Walker: Awesome. So, I think that gives a little interesting perspective because you’ve been in practice prior to when high flow was available and so you can really speak about the progression … You were using CPAP before that I assume?
Dr. McQueen: I was, and obviously all forms of mechanical ventilation as well. I can tell you, I think it’s relevant to those of us, especially those that did, or who have practiced for quite a while, three things in my career have changed the way I practice at the bed side.
The first. Was the widespread adoption of prenatal steroids. That’s where I think we probably saw the first impact on neo natal outcomes, that was markedly noticeable to all of us. Secondly, was exogenous surfactant, and I actually am old enough that during my fellowship I was involved in some of the surfactant trials. My fellowship was at the University of Vermont, and it was one of the greatest privileges I’ve ever had to study and train with the gentlemen at that facility.
And then the third thing, frankly, has been high flow nasal cannula, Vapotherm. It’s actually changed the way that I’ve practiced in the last decade.
Chris Walker: So, Burlington, Vermont, amazing place. Really nice on Lake Champlain I’ve been up there a few times and like it.
Could you just tell me about that … I think it’s interesting talking about that transition from CPAP to high flow and what that meant for your practice, and I guess from a … To give some value to the audience thinking about what that was from an organizational change standpoint as well.
Dr. McQueen: I was lucky to have a supportive respiratory therapy department and a lucky administration as well. When I started this current practice, that was in 2005, and it was just me. There was one physician, so there wasn’t a lot of group consensus to be reached, and I was at one level two hospital. That facility has since grown to a level three nursery, and again, we’ve expanded into six others, so we have seven total.
Because it was a new program and a start up, I think we had people more willing to try things that were being introduced. So, we really started using Vapotherm in 2005. We stopped using it in 2006, like everybody did when it was briefly pulled off the market. Obviously that whole issue was resolved. Then resumed using it again in 2007.
That gap is relevant because that really emphasized to us how much we missed it since we used it in all of 2005, couldn’t use it in 2006. The nurses bugged me every day, when do we get Vapotherm back? And the CPAP is harder to use, the babies don’t like it, the families don’t like it, we don’t like it; it’s just harder to use. Still clinically effective obviously, but just more cumbersome.
When Vapotherm came back on the market in 2007 it was not hard for us to switch and we’ve used it extensively since then.
Chris Walker: I assume, correct me if I’m wrong, everything started mostly as using high flow as extubation support, right?
Dr. McQueen: You know, it did, because that’s what we had heard and that was kind of the standard wisdom. We felt so comfortable with it, within a few months time even, that we said, look, especially on babies that were a little older, 32 weeks and beyond, and who’s respiratory distress maybe wasn’t that severe. We would say, maybe they don’t need to be intubated in the first place. And we were thrilled because we started having significant success at keeping those babies off the vents all together.
As we got more comfortable and a little more aggressive, we started using the Insure Method. We would intubate give a dose of surfactant, extubate directly to a high flow nasal cannula. Probably from 28 weeks and above it was rare for us to use the ventilator anymore.
Chris Walker: And that’s amazing right, because the real goal with infants in respiratory distress is to prevent prolonged mechanical ventilation because of all the associated morbidities with it, correct?
Dr. McQueen: It absolutely is. You know with all do respect to the really well done and well-designed trials that have used intubation and surfactant administration as a marker for treatment failure, I think for the purpose of that study obviously it was. They can define it however they want.
From a clinician pragmatic stand point at the bedside, treatment failure is when the baby ends up intubated for weeks on end, or even days on end. So, we don’t consider giving surfactant a bad end point, and if it keeps the baby from being intubated it’s just a good adjunct.
Chris Walker: Sure. Let’s hone in right now on post extubation support. Earlier in 2016, the Cochrane Review was published for analyzing high flow nasal cannula in comparison to CPAP for post extubation support. Could you just walk me though what conclusions you draw from that paper?
Dr. McQueen: Yeah, I think it actually looked at a fair number of studies, 15 or so, comparing high flow nasal cannula with just other none invasive means of respiratory support. And I think there were two significant takeaways.
One, is that there was no clinical difference between the two. So, it sort of validated the efficacy of high flow nasal cannula. Secondary outcomes have always kind of reared their head, and I think the Cochrane even supported that. There was less nasal trauma with the high flow nasal cannula, and even a trend towards less pneumothoraces.
Chris Walker: Mm-hmm (affirmative)- so nasal trauma, that’s really one of the big adopters towards adopting high flow I think, besides the clinical efficacy, using high flow has been shown in all the randomized control trials, as far as I know, to significantly reduce nasal trauma. Could you just speak to that in your experience and your practice?
Dr. McQueen: It’s absolutely true. From both comments that you made, as far as I know as well Chris, in all of the trials when secondary outcome measures do include nasal trauma the high flow nasal cannula has been superior to the CPAP device. Clinically using this now in several thousands of babies over the last 12 years, again in level two and level three settings, we’ve absolutely seen that.
The ease of use, I think is probably a corollary to that. It’s just comfortable. The babies don’t fight it, the moms can do kangaroo care. We’ve had 26, 27, 28 weekers doing kangaroo care on high flow nasal cannula. It’s really been … It’s one things that’s changed the way we practice medicine.
Vapotherm is so much easier to use than CPAP, that I think there’s a kind of snowball effect. The babies are more comfortable, the nurses are more comfortable, it makes the families more comfortable. There is kind of a momentum built up.
Certainly when it’s introduced into our nursery we were like everybody, is this going to work and do we know how to use it and are we doing the right thing? The first time we extubated, I think even a 28 weeker, after giving surf, we all looked at each other and said, are we sure? Then obviously nobody left the bedside. But, as our confidence grew our unit has so bought into it that it’s just given. I can’t tell you the last time we’ve actually used CPAP.
It’s a tool that we still do utilize, but in our level two nurseries hardly ever. It’s almost all high flow nasal cannula, it’s Vapotherm almost exclusively. Even in the level three nurseries, we use ram cannula, we use the oscillator, we use conventional ventilation, we use all the tools. But, it’s amazing how our ventilator days have decreased and how our CPAP use has decreased.
Chris Walker: I see, I think a lot of people see, and you were kind of ahead of the curve, the momentum that’s building and the randomized control trials that have been published. Most recently the 2016 trials, and the way that I saw it, it kind of started in the 2013 timeframe where you look at post extubation support and then kind of move to, okay now that we can kind of get kids of the vent and support them that way, now let’s look at preventing intubations.
There was two major trials published in 2016. One by Ana Lavizzari out of Italy, in Fabio Mosca’s group. As well as the Hipster’s Trial out of Australia and the UK I believe. Just kind of talk me though the differences in those trials and what that’s meant for your practice.
Dr. McQueen: Yeah, that’s a good observation because the progression of the clinical trials that have come out has really mirrored what we saw in our 12 years of experience thus far, and that is starting with post extubation support and progressing to perhaps we can keep the babies off the ventilator and extubated all together.
The Hipster Trial, actually I’ve received a lot of correspondence on the Hipster Trial, because the initial takeaway was, oh my gosh the CPAP is so much better than high flow nasal cannula. Again, the upmost respect for that, those researchers and trial was incredibly well done. A couple of comments, of the 278 babies in that trial that were randomized to high flow nasal cannula, about 2% of them, six babies were on Vapotherm, so I think that caught my eye for one thing. If there is a difference between devices that would come into play, that’s certainly a worthwhile observation.
Secondly, that was one of the trials that decided to mix surfactant administration and end point in defining treatment failure. While I respect that, and that’s obviously great for a trial design if that’s how they wanted to look at the outcomes. What I really took away from that was for stiff noncompliant surfactant deficient lungs, CPAP works better than high flow nasal cannula. And I thought, yes it does.
I didn’t think it was a stretch to find that at all and I think if your goal is to try to not administer surfactant, CPAP probably does increase your odds. Of note, if you look closely at that trial, there was kind of a rescue branch, if the babies failed high flow nasal cannula, they were switched over to CPAP and the likelihood of being intubated either just from CPAP or high flow nasal cannula and that switch to CPAP was virtually identical. There really was no statistical difference in that given the nasal trauma discussion that we just had, you should really argue, if you read it closely, you should still start with high flow nasal cannula, switch to the CPAP if the patient meets your failure criteria and then either proceed to the surfactant or more aggressive support as needed.
In my clinical opinion, again, I think you can actually use the surfactant, not willy nilly, we don’t give it prophylactically in the delivery room anymore, there was a time when we all did that. But, if the FI02 starts to hit 30, 35, 40% that’s the criteria that most people use clinically and in the studies, that have been done. If the baby has air bronchograms, if he’s working hard to breath, if you think he has RDS and is surfactant deficient, treat him with surfactant. You won’t need to have him on the ventilator and chances are good you won’t need to switch him over to CPAP either.
Chris Walker: Okay. We talked about he Hipster Trial, and only six patients being treated on Vapotherm in that trial, let’s switch gears now to the trial that was done out of Italy, published in JAMA Pediatrics by Ana Lavizzari and colleagues, that used exclusively Vapotherm in that trial. Let’s just try to hone in on the differences and then the conclusions that you draw from that one.
Dr. McQueen: Yeah, Dr. Lavizzari’s trial showed again that there was no difference between high flow nasal cannula and you’re right Vapotherm exclusively, or CPAP, either CPAP or BiPAP, what was the control group.
I liked a couple of things about that, the fact that she took the plunge and said, yeah, let’s do test this for primary support for RDS, because again, I think that’s what we’re evolving to. Secondly, she used surfactant. She set a criteria, it was either 35 or 40% FI02, but if the babies met criteria for surfactant, which ever arm they were randomized too, they got the surfactant. Again, she found no difference between the two modes of respiratory support.
There was, I think she could have even been more aggressive in that trial because she limited her high flow perimeters to six liters per minute and we know when the infants have Vapotherm, it’s approved to go as high as eight liters. Given the insufflation mechanism of action of Vapotherm, I think she even short changed herself a little bit by to maximizing that. But still, no difference and again, the secondary measure showed less nasal trauma and less pneumothoraces.
Chris Walker: It’s interesting you mentioned that ’cause I had actually been able to have a conversation with her just a few months ago, and I asked, I always ask research about their trials, what’s one thing that you would change if you could go back and do it all over again? And she had said that she would have gone up to eight liters and seen how that went.
I think that’s a nice segway into some of the work that Dr. Yoder been doing, that you’ve been a part of, in looking at trying to find consensus on how to administer high flow and so, I’d love if you could talk us through a little bit about that.
Dr. McQueen: Yeah, thank you for sharing that, I didn’t know Dr. Lavizzari felt that, I’m glad she made that observation and reached that conclusion because again, up to eight liters is approved and safe.
Dr. Yoder has been doing some incredible work, like he always does, and among other things he presented at Hot Topics just this past year and there will be a paper shortly submitted for … Coming out in publication on consensus use of high flow nasal cannula. He had seven different investigators from across the globe. I was privileged to be one of the clinicians that got to be surveyed in the Delphi Method questionnaire that he used to define consensus.
Virtually all, not virtually, all of the investigators did agree that up to eight liters was the maximum in the baby. Nobody uses more than that, I’ve heard, anecdotally some reports of colleagues that were trying to exceed eight liters, it’s not approved for that I think we need to be careful, but up to eight liters seems to be the consensus among a wide spectrum of investigators.
Chris Walker: Excellent. I suppose in that paper they reached pretty uniformed consensus on using it as post extubation support, meanwhile I’m not sure that we fully have drawn conclusions on how to administer it as a primary support. I think maybe instead of guiding the detail on that, it would just be interesting to talk about how you use it in practice in both primary support and post extubation support, there’s differences in flow or anything. That would just be interesting to the audience.
Dr. McQueen: You’re right, you remembered his presentation well if you were there because that was exactly right. There was a strong consensus to use it for post extubation support and there was a slight majority to … That high flow nasal cannula could be used for primary respiratory support. But, it was not the same degree of consensus as the post extubation.
Again, just speaking for our clinical experience, we use it very aggressively for primary support right now. And to repeat again, babies 28 weeks and above, unless they have decreased respiratory drive for some reason, a hypoxic event, perhaps mom was severely hypotensive and the baby’s born with Hypermagnesemia and respiratory depression for that.
Assuming a normal respiratory drive, just run of the mill so to speak prematurity and RDS, 28 weeks and above, we have incredible success at never having those babies on the ventilator. Probably 20 to 30% of them do get a dose of surfactant, again not 100% at all and probably not even half. Below that, it’s kind of a sliding scale. We’ve had 26 week babies that have had zero ventilator days, which is amazing.
Chris Walker: Amazing.
Dr. McQueen: It is. It’s changed the way we practice. That’s not commonplace, I don’t want to give the impression that, oh gosh we’re at 26-weekers, we don’t use the ventilator. Not true at all, but for maybe 10 to 20% of those 26 week babies, we think that, again, just clinical experience, we think there’s almost a profile, if mom doesn’t have corio, you’re not worries about the baby being septic, mom had prenatal steroids, the baby doesn’t have any respiratory depression. Kind of a prime candidate as it were.
But, with that, and again with the administration of surfactant, not prophylactically but aggressively if we believe that the baby is surfactant deficient and starting to show increased FI02. We don’t let them tire out and work hard for hours end until they hit 40%. If they have air bronchograms, they’re working hard and they’re that early gestation, we treat them, We extubate them to high flow, sometimes we have to escalate to CPAP or RAM cannula or to even intubation. It absolutely still happens, all those tools are fair game.
Getting the nursing staff the respiratory therapist, your physician colleagues bought in to making the effort and method, we’ve just had incredible results.
Chris Walker: Awesome. One piece in the Hot Topics, that I found really interesting was just the importance, the criticality of using … Properly targeting oxygen saturation levels.
I was wondering if you could just talk me though that in practice day to day, what your target saturation’s are and how you manage that.
Dr. McQueen: You know, I think it’s probably fairly typical. No one I think has reached complete consensus on what are the right O2 saturation’s. But, I would wager that we’re within the standard deviation of what is a national practice between 88 and 93% is kind of a typical target for us.
If we start to hit, again, FiO2’s are 30, 35, we start thinking surfactant pretty hard and at 40% I’d say it’s pretty rare for us not to. There’s obviously, like any practice, there’s practitioner variation even within our own group. Some folks will wait a little bit longer. Work of breathing, part of it just isn’t the FiO2, we’re standing there looking at the baby and if there’s significant work of breathing and retractions and poor air movements, again, we think we can help. We don’t have to let a check box be reached before we intervene on that patient if we’re standing there looking at him with our own eyes.
Chris Walker: Definitely. So, correct me if I’m wrong but, I think you mentioned two Level II NICU’s in the greater Phoenix area, as well as five level, excuse me…
Dr. McQueen: Switch.
Chris Walker: Two level threes, and five level twos, and so I kind of want to focus in on the level two NICU’s, because I think there’s a great opportunity for them to start using high flow nasal cannula and then reduce possible transportation’s and then escalations to mechanical ventilation, increase family satisfaction and not have to move to a different hospital.
I just want to see if that holds water in your experience.
Dr. McQueen: I have nothing to add. It’s exactly the right question. One of the biggest … Certainly all of the things we’ve been talking about on level three utilization holds true. For level two nurseries, this absolutely can be a game changer in program development and in sense of maternal satisfaction.
We have … I can give you one example and show you some data on this, this is a level two nursery in the periphery of the greater Phoenix Metropolitan area. Where we started proving the high flow nasal therapy model in September of 2010.
You can see that in the years prior to our starting this is a facility that has about 1700 deliveries a year, so it’s not huge. But, even with just 1700 delivers a year, prior to the introduction of the aggressive use of high flow nasal therapy, 30 to 40 babies a year were transported out of this hospital into a level three nursery.
This slide shows since we implemented the model, the number of transports per year has fallen to about two or three per year.
Chris Walker: Wow.
Dr. McQueen: It’s a 20 fold reduction in transports. It’s unbelievable.
This slide, interestingly enough, just because we looked at the number of Vapotherm cases, it basically mirrors the number of transports that use to be sent out. That’s why they’re saying. Predicatively from a level two nursery a lot of those babies, most of them were sent for respiratory issues, not always, and we still transport out some babies. But, for routing respiratory support we do give surfactant in our level two nurseries, of note we also have in house 24/7 nurse practitioners in those level two nurseries. So there’s good clinical backup for the kids, so that allows us to implement the therapy safely and be more on it.
Again, a 20 fold decrease in transports that has to catch any administrations eye and any payers eye, in this cost conscientious health care evolution we’re all caught in the middle. Maternal satisfaction, you’re exactly right, we’re not separating the moms and babies. The OB’s are happier, they get to keep moms there and deliver at that community facility instead of sending them out.
Level two nurseries should be all over Vapotherm, and I know I’m a little bias, but we have the data to back it up.
Chris Walker: Excellent. A lot of the things you talk about are ease of use, so in a level two that may not have a full-time neonatologist on staff, I think that ease of use plays a big role. I was wondering if you agree and what you have to comment on that.
Dr. McQueen: It does. As opposed to CPAP, which I would be a little bit to reluctant to use if there weren’t nurse practitioners in house 24/7. We use CPAP in the level two nurseries too, just rarely anymore.
But, because of the risk of nasal trauma, because of the risk of pneumothoraces and acute respiratory deterioration, we would prefer not to use it. If we could use Vapotherm instead we do, and it is so easy to use. While we do employ a 24/7 in house model with our advance care providers, it’s because we’ve chosen to do it that way, with proper education, I really want to emphasize that. With proper education about how the cannula interfaces to the baby, the mechanisms of action. I think a level two nursery with immediate response from the neonatologist could also safely use this as opposed to CPAP.
Chris Walker: I think that was a good segway into a paper that you were a part of that was published in 2013, about the economics associated with high flow nasal cannula usage in a level three NICU.
I just wanted to open the floor to you about your experience and the part you played in the paper, as well as the conclusions that you’ve drawn and how it’s impacted your practice.
Dr. McQueen: Great, thank you for noticing that and for asking about it. You’re right, it as in the Journal of Health Economics and Outcomes Research in 2013. Dr. Young Peach was the lead author of that.
This was our experience and quantification of ancillary cost savings in a level three NICU, our biggest and busiest level three NICU. We basically did a before and after. The six months before we implemented the high flow therapy and the six months after we implemented Vapotherm in that level three NICU.
What we showed was about a 25% decrease in ventilator days, we showed a 50% decrease in chest x-rays, right, the babies weren’t intubated so we didn’t need to get a chest x-ray every day and make sure the ET tube was in good position. We showed a 50% decrease in blood gas utilization. Because a lot of this is clinically monitored we follow the babies oxygenation via pulse oximetry, his work of breathing is a good indicator of his ventilation status. If we have any question we get an x-ray, if we have any questions we get a blood gas. But, again a 50% decrease in those ancillary services.
Even in the level three NICU’s it seems to make an impact. We didn’t look at even downstream measures, because we had fewer blood gases did we have fewer blood transfusions, because we had fewer blood transfusions did we have to hold the feeds less often and did we get to full feeds faster. We didn’t even look at any of that, just the ancillary support services told us that we were on the right track and being more cost effective with this even in a level three NICU.
Chris Walker: You mentioned the pressure, right? A lot of places and doctors sometimes have reluctance to implement high flow, especially at the liter fluids you’re talking about because of, I don’t know the pressure type of concerns. And I think it’s interesting when we look at all of the randomized control journals with high flow compared to CPAP, both extubation as well as primary support, there’s two major difference that I see.
One is significant decrease of nasal trauma and the second one is, is there’s either equal or at time significantly less instances of pneumothoraces. And with that, I think it’s a reasonable conclusion to draw that you’re not generating any types of dangerous pressure.
What do you think about that?
Dr. McQueen: I totally agree. Applied correctly you’re not.
When we started we had exactly the same concerns, how much pressure are we generating and worse. We didn’t know. Every mode of mechanical respiratory support is based on pressure. Doesn’t matter if it’s a conventional ventilator an oscillator, an NIPPV with RAM cannula, CPAP obviously speaks for itself. It’s based on pressure.
This is a whole different mechanism of action. That flow is going to generate some pressure, especially during exhalation. But., it’s about equivalent … Some researchers have shown that to a baby doing purse lipped breathing during exhalation, and again, with proper application, meaning room for egress of that pressure build up. Don’t occlude the larynx, have the mount open, there’s no reason that you should be generating any dangerous levels of pressure. There’s no way it should be transmitted to the lungs.
Chris Walker: And that’s what it’s all about, right? At times, if you can, the mouth open is an excellent scenario to have. But, it’s really about fitting the prongs proper to less than 50% occlusion, and with that, there’s plenty of space for gas egress even with the mouth closed scenario.
Dr. McQueen: Correct. I think the nasal prong is absolutely key and to illustrate that even further, Vapotherm even has, as you well know a uni-prong cannula to kind of demonstrate that you’re not trying to generate pressure. In fact just the opposite, you’re trying to allow room for egress. But, certainly the nasal occlusion is the main thing to avoid, but you can’t always keep the baby’s mouth open, sometimes they close it. When you’re trying to do CPAP and want it closed, sometimes they open it.
It’s hard to give that one but a perfect fit in our world is when there is 50% occluded or less and the baby’s mouth open. We’ve just had no issues going up to seven and eight liters per minute.
Chris Walker: Any last comments?
Dr. McQueen: Thank you for letting me participate in this.
Chris Walker: It’s been great, right?
So, the idea is that we continue this on, on a regular basis and maybe in a year we come back and cover some of the interesting new evidence. And just kind of open up the conversation to everyone and try to be an educational resource and a tool that people can go to, to learn and share experience.
Again, you’ve been a proponent for high flow for a long time, and so we really appreciate you joining us today. It’s been good to see you.
Dr. McQueen: I appreciate you again inviting me. I use Vapotherm because I believe in it, I don’t use it because you invited me, so thank you.
Chris Walker: Thank you.