Careful. - Is Protocol-Driven COVID-19 Ventilation Doing More Harm Than Good?
We won't know for some time, but seems there is some credibility attached to this position. Freud was condemned by his colleagues at first. Just saying.
Physicians in the COVID-19 trenches are beginning to question whether standard respiratory therapy protocols for Acute Respiratory Distress Syndrome .. https://emedicine.medscape.com/article/165139-overview (ARDS) are the best approach for treating patients with COVID-19 pneumonia.
At issue is the standard use of ventilators for a virus whose presentation has not followed the standard for ARDS, but is looking more like high-altitude pulmonary edema .. https://emedicine.medscape.com/article/300716-overview (HAPE) in some patients.
In a letter to the editor published in the American Journal of Respiratory and Critical Care Medicine on March 30, and in an editorial accepted for publication in Intensive Care Medicine, Luciano Gattinoni, MD, of the Medical University of Göttingen in Germany, and his colleagues make the case that protocol-driven ventilator use for patients with COVID-19 could be doing more harm than good.
Dr. Gattinoni noted that COVID-19 patients in intensive care units in northern Italy had an atypical ARDS presentation with severe hypoxemia and well-preserved lung gas volume. He and his colleagues suggested that instead of high positive end-expiratory pressure (PEEP), physicians should consider the lowest possible PEEP and gentle ventilation-practicing patience to "buy time with minimum additional damage."
Similar observations were made by Cameron Kyle-Sidell, MD, a critical care physician working in New York City, who has been speaking out about this issue on Twitter and who shared his own experiences in this video interview .. https://www.medscape.com/viewarticle/928156 .. with WebMD chief medical officer John Whyte, MD.
The bottom line, as Dr. Kyle-Sidell and Dr. Gattinoni agree, is that protocol-driven ventilator use may be causing lung injury in COVID-19 patients.
Consider Disease Phenotype
In the editorial, Dr. Gattinoni and his colleagues explained further thatventilator settings should be based on physiological findings — with different respiratory treatment based on disease phenotype rather than using standard protocols.
"This, of course, is a conceptual model, but based on the observations we have this far, I don't know of any model which is better," he said in an interview.
Anecdotal evidence is increasingly demonstrating that this proposed physiological approach is associated with much lower mortality rates among COVID-19 patients, he said.
While not willing to name the hospitals at this time, he said that one center in Europe has had a 0% mortality rate among COVID-19 patients in the intensive care unit when using this approach, compared with a 60% mortality rate at a nearby hospital using a protocol-driven approach.
Page 2
In his editorial, Dr. Gattinoni disputed the recently published recommendation from the Surviving Sepsis .. https://emedicine.medscape.com/article/234587-overview .. Campaign that "mechanically ventilated patients with COVID-19 should be managed similarly to other patients with acute respiratory failure in the ICU."
"Yet, COVID-19 pneumonia, despite falling in most of the circumstances under the Berlin definition of ARDS, is a specific disease, whose distinctive features are severe hypoxemia often associated with near normal respiratory system compliance," Dr. Gattinoni and colleagues wrote, noting that this was true for more than half of the 150 patients he and his colleagues had assessed, and that several other colleagues in Northern Italy reported similar findings. "This remarkable combination is almost never seen in severe ARDS."
Dr. Gattinoni and his colleagues hypothesized that COVID-19 patterns at patient presentation depend on interaction between three sets of factors: 1) disease severity, host response, physiological reserve and comorbidities; 2) ventilatory responsiveness of the patient to hypoxemia; and 3) time elapsed between disease onset and hospitalization.
They identified two primary phenotypes based on the interaction of these factors: Type L, characterized by low elastance, low ventilator perfusion ratio, low lung weight, and low recruitability; and Type H, characterized by high elastance, high right-to-left shunt, high lung weight, and high recruitability.
"Given this conceptual model, it follows that the respiratory treatment offered to Type L and Type H patients must be different," Dr. Gattinoni said.
Patients may transition between phenotypes as their disease evolves. "If you start with the wrong protocol, at the end they become similar," he said.
Rather, it is important to identify the phenotype at presentation to understand the pathophysiology and treat accordingly, he advised.
The phenotypes are best identified by computed tomography scan, but signs implicit in each of the phenotypes, including respiratory system elastance and recruitability, can be used as surrogates if CT is unavailable, he noted.
"This is a kind of disease in which you don't have to follow the protocol – you have to follow the physiology," he said. "Unfortunately, many, many doctors around the world cannot think outside the protocol."
In his interview with Dr. Whyte, Dr. Kyle-Sidell stressed that doctors must begin to consider other approaches. "We are desperate now, in the sense that everything we are doing does not seem to be working," Dr. Kyle-Sidell said, noting that the first step toward improving outcomes is admitting that "this is something new."
"I think it all starts from there, and I think we have the kind of scientific technology and the human capital in this country to solve this or at least have a very good shot at it," he said.
Proposed Treatment Model
Dr. Gattinoni and his colleagues offered a proposed treatment model based on their conceptualization:
1. Reverse hypoxemia through an increase in FiO2 to a level at which the Type L patient responds well, particularly for Type L patients who are not experiencing dyspnea.
2. In Type L patients with dyspnea, try noninvasive options such as high-flow nasal cannula, continuous positive airway pressure, or noninvasive ventilation .. https://emedicine.medscape.com/article/304235-overview , and be sure to measure inspiratory esophageal pressure using esophageal manometry .. https://emedicine.medscape.com/article/1891791-overview .. or surrogate measures. In intubated patients, determine P0.1 and P occlusion. High PEEP may decrease pleural pressure swings "and stop the vicious cycle that exacerbates lung injury," but may be associated with high failure rates and delayed intubation.
3. Intubate as soon as possible for esophageal pressure swings that increase from 5-10 cmH2O to above 15 cmH2O, which marks a transition from Type L to Type H phenotype and represents the level at which lung injury risk increases.
4. For intubated and deeply sedated Type L patients who are hypercapnic, ventilate with volumes greater than 6 mL/kg up to 8-9 mL/kg as this high compliance results in tolerable strain without risk of ventilator-associated lung injury. Prone positioning should be used only as a rescue maneuver. Reduce PEEP to 8-10 cmH2O, given that the recruitability is low and the risk of hemodynamic failure increases at higher levels. Early intubation may avert the transition to Type H phenotype.
5. Treat Type H phenotype like severe ARDS, including with higher PEEP if compatible with hemodynamics, and with prone positioning and extracorporeal support.
Dr. Gattinoni reports having no financial disclosures.
Seriously - Do COVID-19 Vent Protocols Need a Second Look?
Hey guys, i don't see any conspiracy tinge, junk science suggestion or any other problem, other than questions around managing a new disease, between health professionals around any of this.
Right or wrong that's all it is. Please all read, or listen to, this interview, i think then more may agree with that.
After treating patients with COVID-19, a New York city physician suggests ventilator protocols may need revisiting
John Whyte, MD, MPH; Cameron Kyle-Sidell, MD Disclosures April 06, 2020 [Author(s) John Whyte, MD, MPH Chief Medical Officer, WebMD
Cameron Kyle-Sidell, MD Department of Emergency Medicine, Maimonides Medical Center, Brooklyn, New York Disclosure: Cameron Kyle-Sidell, MD, has disclosed no relevant financial relationships.] ........
VIDEO
This transcript has been edited for clarity.
John Whyte, MD, MPH: Hello. I'm Dr John Whyte, chief medical officer at WebMD. Welcome to "Coronavirus in Context." Today we're going to talk about whether we're managing coronavirus correctly; do we need to think about a change in our treatment regiments? My guest is Dr Cameron Kyle-Sidell. He's a physician trained in emergency medicine and critical care, and he practices at Maimonides in Brooklyn, New York. Welcome, Dr Sidell.
Cameron Kyle-Sidell, MD: Thank you very much. Thank you for inviting me.
Whyte: You've been talking a lot about the number of patients, the percentage of patients dying on ventilators. When did you first notice this trend?
Kyle-Sidell: In preparation of opening what became a full COVID-positive intensive care unit, we scoured the data just to see what was out there—those who have experienced it before us, primarily the Chinese and the Italians; it was hard to find exactly, like the rate of what we call successful extubation—meaning, someone was put on a ventilator and taken off. And that data are still hard to find. I imagine there are a lot of people still on ventilators. But from the data we have available, it appears to be somewhere between 50% and 90%. Most published data puts it around 70%. So, that's a very, very high percentage in general, when one thinks of a medical disease.
Whyte: You've been talking on social media; you say you've seen things that you've never seen before. What are some of those things that you're seeing?
Kyle-Sidell: When I initially started treating patients, I was under the impression, as most people were, that I was going to be treating acute respiratory distress syndrome (ARDS), similar in substance to AIDS, which I saw as a fellow. And as I start to treat these patients, I witnessed things that are just unusual. And I'm sure doctors around the country are experiencing this. In the past, we haven't seen patients who are talking in full sentences and not complaining of overt shortness of breath, with saturations in the high 70s. It's just not something we typically see when we're intubating some of these patients. That is to say, when we're putting a breathing tube in, they tend to drop their saturations very quickly; we see saturations going down to 20 to 30. Typically, one would expect some kind of reflexive response from the heart rate, which is to say that usually we see tachycardia, and if patients go too low, then we see bradycardia. These are things that we just weren't seeing. I've seen literally a saturation of zero on a monitor, which is not something we ever want and something we actively try to avoid. And yet we saw it, and many of my colleagues have similarly seen saturations of 10 and 20. We try to put breathing tubes in to avoid this very situation. Now, these patients tend to desaturate extremely quickly, so these situations have occurred. Still, what we're seeing—that there was no change in the heart rate—is just unusual. It's just something that we are not used to seeing.
Whyte: This is more like a high-altitude sickness. Is that right?
Kyle-Sidell: Yes. The patients in front of me are unlike any patients I've ever seen., and I've seen a great many patients and have treated many diseases. You get used to seeing certain patterns, and the patterns I was seeing did not make sense. This originally came to me when we had a patient who had hit what we call our trigger to put in a breathing tube, meaning she had displayed a level of hypoxia of low oxygen levels where we thought she would need a breathing tube. Most of the time, when patients hit that level of hypoxia, they're in distress and they can barely talk; they can't say complete sentences. She could do all of those and she did not want a breathing tube. So she asked that we put it in at the last minute possible. It was this perplexing clinical condition: When was I supposed to put the breathing tube in? When was the last minute possible? All the instincts as a physician—like looking to see if she tires out —none of those things occurred. It's extremely perplexing. But I came to realize that this condition is nothing I've ever seen before. And so I started to read to try to figure it out, leaving aside the exact mechanism of how this disease is causing havoc on the body, but instead trying to figure out what the clinical syndrome looked like.
Page 2
Whyte: You talked a little about the data from Italy.
Kyle-Sidell: Yes.
Whyte: [From Luciano] Gattinoni. Were you aware of what was going on in Italy before you noticed these observations or did that come after the fact?
Kyle-Sidell: That came a little bit after. And I wasn't aware. I can't even remember the exact timeline. But in my reading, I came upon decompression, pulmonary sickness, which is essentially the bends—when divers dive and come up too quickly—which seemed to mirror the clinical picture of these patients. And in discussions of other people, it came up that they do appear similar clinically. This is not to say that the pathophysiology underlying it is similar, but clinically they look a lot more like high-altitude sickness than they do pneumonia. Regarding, Gattinoni, he published something on March 20th, which was about 2 days before I opened the ICU. I don't know that I read it then, but somehow it got passed around. In my mind, by the time I read what he was saying, I'd come under the impression that this just wasn't what we were used to seeing. It was a high-compliance disease, which every pulmonologist had. Anyone managing a ventilator can see. That's not a question. So when I read his stuff, where he is suggesting that the management strategy that we use is essentially somewhat flipped, at least in these high-compliant patients, it just became more clear that that if we operate under a paradigm whereby we are treating ARDS in these high-compliant patients, we may not be operating under the right paradigm.
Whyte: Have you changed your protocols, then?
Kyle-Sidell: To be honest, I've run into a great deal of resistance within my institution, which is not to say that anyone is trying to stymie the progress at all. These are the protocols that are in every major (and minor) hospital.
Whyte: You talked about in your videos.
Kyle-Sidell: Yeah.
Whyte: Against a long-standing dogma. So what's been the response from your clinical colleagues as well as hospital administrators?
Kyle-Sidell: I started to try to not my own protocols, but to treat patients as I would have treated my family, with different goals—which is to say, ventilation. However, these didn't fit the protocol, and the protocol is what the hospital runs on with the respiratory therapist, with the nurses; everyone is part of the team. We ran into an impasse where I could not morally, in a patient-doctor relationship, continue the current protocols which, again, are the protocols of the top hospitals in the country. I could not continue those. You can't have one doctor just doing their own protocol. So I had to step down from my position in the ICU, and now I'm back in the ER where we are setting up slightly different ventilation strategies. Fortunately, we've been boosted by recent work by Gattinoni, which was formally published today and which does outline the best evidence, based on at least expert recommendations, for changes in our overall protocols. [Editor's note: Dr Kyle-Sidell is referring to an unedited proof, soon to be published formally in Intensive Care Medicine.]
Whyte: Can you tell us what some of those changes are that you're going to make?
Kyle-Sidell: First, I'll describe what Gattinoni was saying, which is that really what we're seeing in ARDS are two different phenotypes: one in which the lungs display what you call high compliance, low elastics; and one in which they have low elasticity and high compliance. To say it simply for people who are not pulmonologists, if you think of the lungs as a balloon, typically when people have ARDS or pneumonia, the balloon gets thicker. So not only do you lack oxygen, but the pressure and the work to blow up the balloon becomes greater. So one's respiratory muscles become tired as they struggle to breathe. And patients need pressure. What Gattinoni is saying is that there are essentially two different phenotypes, one in which the balloon is thicker, which is a low-compliance disease. But in the beginning they display high compliance. Imagine if the balloon is not actually thicker but thinner, so they'd suffer from a lack of oxygen. But it is not that they suffer from too much work to blow up the balloon. As far as how we're going to switch, we're going to take our approach differently from the traditional ARDSnet protocol in that we are going to do an oxygen-first strategy: We're going to leave the oxygen levels as high as possible and we're going to try to use the lowest pressures possible to try to keep the oxygen levels high. That's the approach we're going to do, so long as the patients continue to display the physiology of a low elastance, high-compliance disease.
Page 3
Whyte: Do you feel that somewhere the world made a wrong turn in treating COVID-19?
Kyle-Sidell:I don't know that they made a wrong turn. I mean, it came so fast. I think that one thing we benefit from is that the Chinese and the Italians were hit first and they were hit hard. New York is being hit so hard. It's hard to switch tracks when the train is going a million miles an hour. In that sense, we'd benefit from their shared experience. And I think it's important that we listen to that experience. But I do think that it starts out with knowing, or at least accepting the idea, that this may be an entirely new disease. Because once you do that, then you can accept the idea that perhaps all the studies on ARDS in the 2000s and 2010s, which were large, randomized, well-performed, well-funded studies, perhaps none of those patients in those studies had COVID-19 or something resembling it. It allows you to move away from a paradigm in which this disease may fit and, unfortunately, walk somewhat into the unknown.
Whyte:You're advocating something a little different. What are the consequences of you being wrong, albeit well intentioned?
Kyle-Sidell:Right now we have some of the greatest experts in the world giving their opinions. By that, I mean the Italians and Dr Gattinoni. I certainly could be wrong. What I'm asking for is not even not an immediate change in the ventilation strategy, because I'm critical care trained, I'm not pulmonary trained and I'm not as experienced as many around the country and many in my own hospital. But what I would like to see is all of these great minds get together. If they can accept this notion that perhaps we need to switch paradigms, and they're able to better create a path forward that fits the disease. I would gladly follow them. Really, what I'm asking and what I'm requesting is that all of the experts in the field get together and perhaps come up with some fresh recommendations.
Whyte: You've been active on social media, as I mentioned. Are you a whistleblower?
Kyle-Sidell: This is sort of my first foray into social media. I don't know that I'm a whistleblower. I don't know that anyone was trying to purposely do any harm. I think that, all of the physicians involved and all of the nurses and everyone writing protocols—everyone is working as fast and as hard as they can with good faith and pure intention. For me, I saw something clinically that didn't make sense. And seeing that New York is about 10 days ahead of the rest of country, I just felt compelled to get that information out.
Whyte: Has speaking up impacted your professional career?
Kyle-Sidell: I don't know yet. In one sense, I have not felt qualms about it. For whatever reason, I trained in critical care and I was an ER doctor, and I think part of that allowed me to see it a little bit better. Because if you just received these patients in the ICU on breathing tubes, it's very hard to see this physiology. I was running around the hospital from the ER to the floors to the ICU, and I saw them in all stages of this disease. When you see them in all those different stages, you're able to see that something physiologically doesn't make sense. So, in a way, I do feel that somehow my training and my position, being in New York City, allowed me to see this. I have not felt any conflict about coming forward, per se. And I don't know what it will do for my career, but I hope that people know that I'm not doing this with any kind of— I'm not trying to stymie anything. It's really that I'm doing what I think is right.
Whyte: What are the two things that we need to be doing right now to really address the mortality?
Kyle-Sidell: That goes back to your question of "if I am wrong." We are desperate now in the sense that everything we are doing does not seem to be working. So we've reached a point that most other diseases have not reached, where many physicians are willing to try anything that may help because so little seems to be helping. One of the reasons I speak up, and I hope people at the bedside speak up, is that I think there may be a disconnect between those who are seeing these patients directly, who are sensing that something is not quite right, and those brilliant people and researchers and administrators who are writing the protocols and working on finding answers. The first thing to do is see if we can admit that this is something new. I think it all starts from there. I think we have the kind of scientific technology and the human capital in this country to solve this or at least have a very good shot at it. I think the second thing is that whatever collaboration we can do with those who came before us—and by that, I mean the Chinese and the Italians and the Egyptians and whoever else has experienced this—if there's anything we can learn from them, I think we need to open up and be ready to receive their help.
Whyte: Dr Kyle-Sidell, I want to thank you for speaking up and sharing your story with us.
Kyle-Sidell: Thank you very much. I appreciate you allowing me to speak.
Whyte: I want to thank you for watching "Coronavirus in Context." I'm Dr John Whyte.
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