Hello, my name is Natalie Napolitano and I will be talking about controversies in part 2.0, the use of non-invasive respiratory support. These are my disclosures. You can determine if my involvement with these companies has caused any sort of conflict of interest at the end of this talk. Our objective for this talk will be reviewing the available literature and recommendations for the use of noninvasive ventilation with pediatric ARDS. And we will take a look at also the literature that's available and any recommendations for use of high flow nasal cannula for the treatment of pediatric ARDS. Treating pediatric ARDS with noninvasive respiratory support is very common in just about every pediatric ICU. And this is a reasonable first step for treatment of respiratory failure. As we're trying to really prevent all of the hazards and adverse events that are associated with tracheal intubation, as well as long-term mechanical ventilation. To keep us all on the same page, moving forward from a definition standpoint, just wanna review what I'm talking about when I speak of high flow nasal cannula or noninvasive ventilation moving forward for this presentation. Unfortunately, a lot of publications have used different definitions over time. It muddies the water a little bit when people are talking about noninvasive support. So to get us on the same path, start things off. When I'm talking about high flow nasal cannula, I'm speaking of the application of heated and humidified oxygen via binasal prongs that have a 60 to 80% occlusive fit. We are not looking at 100% occlusive fit in the NAERS for this. Flow rates are gonna be higher than those that are standardly used for a nasal cannula for that age patient. So in general, for infants, we wouldn't go above two liters per minute with dry oxygen. For pediatrics, four liters per minute and an adult patient six liters per minute. Anything heated and humidified above those flows, that is what I consider high flow nasal cannula and that's what I'm talking about when I refer to that going forward. For noninvasive ventilation, we're talking about the application of some continuous set level of airway pressure. This could be CPAP, which is a single level of pressure or bi-level noninvasive ventilation with a set rate two levels of pressure. But there is a set level of pressure that is received by the patient. And we know this is received because we're using some sort of an occlusive fit to nasal prongs or a nasal mask or a full face or an oral nasal mask, as well as the helmet. The application or use of the ram cannula or any sort of cannula, short cannula interface with a 60 to 80% occlusive fit, even though you're setting a pressure, there have been several studies that show this doesn't actually deliver that pressure. So that is not considered noninvasive ventilation for the sake of this talk and within the police guidelines. So NEARS oftentimes is referred to both of these or any sort of noninvasive respiratory support. And you'll see that term NEARS or N-I-R-S in the plea to guidelines, as well as within this presentation. But that way we know kind of, we're all starting at the same level here. Ultimately, we have questions when using noninvasive ventilation in PARDS. What is the effectiveness in the support of PARDS really help? What settings do we use? When should we consider success? We should be predefining success with noninvasive ventilatory support, just like we do with all other forms of therapy to know if we're actually hitting that metric. And then when do we admit defeat? What is failure or when is failure in this population? And when we're talking about failure of therapy, we need to take our personal egos out of it. It has nothing to do with us, is simply the severity of the disease and the child needs more support or it's us not having the tools that we need to appropriately do our job, which we'll get into when we talk more about interfaces. But we really should be defining what failure is as well as success, so that we know when we should be pivoting towards our backup plan for these children. So what is the evidence available to support the use of noninvasive ventilation and the treatment of PARDS? Well, for those that are possible PARDS or patients that are at risk for developing PARDS, who are at that point in therapy that they're receiving either simple oxygen therapy or you've escalated already to high flow nasal cannula, and they're continuously showing signs that they're leading towards respiratory failure, that it is absolutely reasonable to try noninvasive ventilation if you can improve their status so that you can avoid intubation. Unfortunately, there are really only two randomized control trials that help us get to this decision. And most of them are observational trials. In the body of evidence that we looked at, there were 12 observational trials that added to this, but really the Jans et al in PCCM in 2008 showed a 28% noninvasive failure versus 60% versus those who were on high flow nasal cannula or simple oxygen therapy. And then Peters et al in 2018 in PCCM also showed a much higher noninvasive failure rate of 48% versus 24% in the high flow nasal cannula or simple oxygen therapy group. So a little bit of differing results there. However, we still think it is reasonable. The observational trials gave us some really good information overall. With all of these trials, there was almost 1500 subjects that were included and the overall failure rate was 42%. So with a failure rate of 42%, you're not gonna have, it's almost a flip of the coin here as to whether or not noninvasive is gonna help avoid intubation. It's worth giving it a try, but we really need to have some clear set goals for the individual patient that says, if we are not improving by this much at this time, we should proceed the intubation. That way they're not in extremis making our intubation procedure that much riskier. And looking further at this support, breaking it down, our benefits is really the avoidance of intubation, of the paralysis, of the sedation, the long-term medications and potential delirium associated with long-term mechanical ventilation and the added length of stay in the ICU and in the hospital. Clear benefits that we can all see that if it works, it's going to work well. The harms however, is that we often don't have clear goals of what benefit is of what successes or what we would consider failure to be. So we delay intubation and we prolong the instability of the patient making the intubation procedure a bit riskier than it really should have been. And also potential having self-inflicted lung injury with the patient if they're dyssynchronous with their noninvasive ventilation. Our balance is really trying, it's that 50-50 flip of the coin almost. If you can successfully avoid intubation, there's great benefit, but really we need to have care and take ourselves out of the equation when we're looking at failure of therapy. So within the PLEAT guidelines, we are recommending a time-limited trial of noninvasive ventilation to see if there's any improvement. If you're not seeing that improvement within the first six hours of positive pressure therapy, you really should progress to intubation. This is any worsening of symptoms such as an increased heart rate, increased work of breathing, retractions, worsening of your SF ratio. For severe parts or any sort of other severe organ dysfunction that's associated with their lung issues, then you should consider intubation much sooner. There is some evidence from two different trials that suggests the use of noninvasive and high-flow nasal cannula prior to intubation in your immunocompromised kids really increases the risk of mortality. So in this subset of population, you're not gonna really wanna spend a lot of time on noninvasive ventilation or high-flow nasal cannula or even give it a trial. Progressing to intubation, it actually reduces mortality in this group of kids. Now, how do we really recognize noninvasive ventilation failure? Looking specifically at the SF ratio, there were three observational trials that gave us the biggest input here. And this, you can see them listed here. In Ravi Kamani's trial in 2019, they showed a failure rate of 50% of noninvasive when looking at the SF ratio. And the PF ratio, we also see a 50% failure rate within the parts subgroup of a large observational trial in 2013, of almost 400 children. And then in Marty Pond's trial in 2013 as well, which is another retrospective observational trial, a little bit smaller than the others of 34 kids, but they showed a failure rate of 21% when looking at the SF ratio. They all, of these trials, kind of looked at different time points as to in what that cutoff is, but it can be a really good objective measure as well as looking at your other clinical signs, such as your heart rate and respiratory rate, to really tell within the first two to six hours of them looking like they are possible parts to know whether or not they're moving forward, or if you really should be progressing to intubation. I did mention specifically about the immunocompromised patients. There are several trials listed here that you can see. This first one by Peters in 2018 that saw a 30-day mortality rate was higher. And those who use noninvasive early. And Lindell et al's group in 2022, another retrospective trial that saw increased mortality when there were more than six hours of high flow or noninvasive prior to intubation. And then Rowan's group in 2021 saw also that noninvasive ventilation failure was associated with reduced hospital mortality. So there's some clear literature in this group that noninvasive ventilation really potentially prolongs their instability and to the detriment of the child. So progressing to intubation when you have an immunocompromised child is really the best choice here. So weighing our risks and benefits. For doing this time-limited trial, really that intubation with no improvement and noninvasive ventilation is better. There are, even though there's additional risks to the intubation, there's also additional risks to the increased instability in the patients. There is potential harm with intubating your patients that might recover on noninvasive ventilation, but it's really hard to tell with kind of that 42% overall failure rate, which ones you can pick to say these ones are gonna make it and these ones aren't. So with a low level of evidence of recognition in this group we're really saying watch these kids closely for the first six hours. And if you're not seeing good improvement then pull the trigger. So we've chosen to really use noninvasive ventilation on our patients or on a given patient. So what's the best way to manage this when we're doing it for the greatest success within that first six hours, if we're all in agreement of this time-limited trial? You really wanna make sure that you're choosing an interface that provides the most efficient synchrony with the patient. One, they're gonna tolerate wearing and even potentially with some encouragement from their parents, from everyone around them to keep the mask on. Sometimes the things that look the worst to us actually work really well for the children. So the helmet or the full face that goes over their eyes, children really like those. They can see unobstructedly without the nasal masks or the full face masks. If you're really trying to see if you're gonna get them over the hump because they're doing bad, a full face or some sort of an oral nasal mask is probably best to eliminate leaks and really be able to capture them with synchrony. But you really wanna make sure that you have a good interface for the size of your child. We all know that we don't have great options out there. There may be one or two sizes and everything's been on back order for the last year. So if you have them, but using an ineffective interface can be a significant problem for this population that can lead towards failure because it really is gonna help lead to asynchrony and potentially a self-inflicted lung injury which could make things worse. You could give a little whiff of sedation to really help if there's poor tolerance. That's something to really watch closely and needs to be taken case by case consideration with the child. And using some inspiratory pressures to help augment their breaths and their inspiratory muscle work if they're able to synchronize is fantastic. Otherwise, if they're not, CPAP really may be your best choice to not cause additional injury. And if they can't make it with CPAP, then they can't make it with CPAP. And really monitoring closely for skin breakdown, for any sort of gastric distention and vomiting. If you're using a full face mask, they're gonna be swallowing a lot of air either way, but your younger children can't tell you that they're gonna be sick. They can't take off their mask. We're looking again to worry about their asynchrony which can be a source of barotrauma. And in their eyes, different types of conjunctivitis. If you're adding any in-health therapies into the mix with your full face or helmet masks, where their eyes are going to be within the mask, then you really wanna be cautious of the medications that you're giving because you can cause additional injury and irritation to their eyes as well. Talking about high flow nasal cannula. In the Pleak 2 guidelines, we are not recommending that we use high flow on patients who are at risk or have possible PARDS. The reason for this is there is just not enough research out there that gives us what the clinical indications are for the use of PARDS. We really need some more information about the proposed physiologic mechanism that's gonna help within this disease process. And we need a better way to shake out which patients are gonna benefit and which ones won't. There's this six hour limited timeframe that we're recommending that you're using non-invasive support at all and recommending the biggest bang for your buck within that timeframe. If they're progressing more towards failure with high flow, there's another delay, and then you get on non-invasive, it may be too late for that really to be able to help you. So at this point, we're recommending no use of non-invasive ventilation with possible PARDS. So in conclusion, we all know that non-invasive ventilation is widely used for the treatment of respiratory failure in children. And in a subset of those with possible or probable PARDS, it can be beneficial. There is, however, a little bit of a larger subset that does fail non-invasive ventilation and moves on to intubation. We need to be able to monitor these kids closely and recognize worsening disease process and non-invasive failure, preferably within that first six hours of therapy, and then just making that decision relatively quick if we should move to intubation. High flow nasal cannula is not recommended to be used. We definitely need a lot more research there. Thank you all very much for taking the time. Here is my email. If there are any additional questions or comments, I would be happy to talk with you all.

non-invasive respiratory support

pediatric acute respiratory distress syndrome (ARDS)

observational trials

intubation

patient interface selection