NEW YORK (Reuters Health) – Physicians worldwide have been asking their COVID-19 patients to lie on their stomachs to improve breathing and blood oxygen levels, but the practice has been based on scant evidence. Now more data are in, and they suggest prone positioning can reduce the need for intubation in cases of acute hypoxemic respiratory failure requiring high-flow nasal-cannula oxygen, according to new research.
In those cases, “awake prone positioning should be implemented as standard of care,” co-author Dr. Jie Li of Rush University in Chicago told Reuters Health by email. “And more importantly, we should make efforts to improve patients’ comfort under prone positioning, in order to help them stay at least eight hours daily in awake prone positioning.”
For every 14 patients who lie prone while awake instead of receiving standard care, one can avoid intubation, according to the research, a “meta-trial” of six randomised controlled open-label superiority trials. And the longer patients lie prone, the greater the benefit, the results suggest.
The study included 1,121 patients at six hospitals in six countries – Canada, France, Ireland, Mexico, USA and Spain. The patients all needed respiratory support with high-flow nasal cannula for acute hypoxemic respiratory failure due to COVID-19 and were randomized to prone positioning or standard care.
Intubation or death within 28 days was considered treatment failure, the primary outcome, Dr. Li and her colleagues explain in The Lancet Respiratory Medicine.
Forty percent of the patients who lay prone were intubated or died within 28 dies, compared to 46% of the patients in standard care (relative risk, 0.86; 95% confidence interval, 0.75 to 0.98).
One of the concerns with prone positioning has been that a delay in intubation may lead to complications and even death. This study suggests otherwise: The rate of intubation was 33% with prone positioning versus 40% with standard care, and 28-day mortality was 21% and 24%, respectively.
“So that is reassuring to me that there’s really nothing to lose by trying it,” said Dr. Jason Weatherald of the University of Calgary’s Libin Cardiovascular Institute, in Canada, who coauthored a linked editorial.
“The sort of message of caution is that clinicians need to be on (top of) patients to do it. And if they’re not going to be able to do it for – who knows what the magic threshold is – but if they can only do it for two hours, it’s not working. And they should probably abandon it,” he told Reuters Health by email.
That threshold is one of several questions that remain, according to Dr. Li.
“More studies are needed to validate the relationship between the duration of awake prone positioning and patient outcome, to explore the optimal timing to start and stop prone positioning, and to identify the patients who will benefit most from awake prone positioning,” Dr. Li said.
A notable aspect of the study is its unusual design, as Dr. Weatherald and his coauthors points out in their editorial. The “meta-trial” is a new concept that combines aspects of a traditional international study with a meta-analysis. Dr. Weatherald likened it to a pre-planned meta-analysis.
In this study, the heads of six research teams that were already investigating prone positioning collaborated to change the parameters of their studies such that the findings could be combined. The result is similar to a top-down international study, but for less money and with less time lost to contracting and other paperwork. The data are not as homogeneous as they would be in a traditional study, Dr. Weatherald said, but they are less heterogeneous than they would have been as a meta-analysis.
“What they did was actually really brilliant and allowed them to arrive at this answer a lot quicker,” Dr. Weatherald said. “This is the first time where I’ve ever seen it done in a prespecified way. And they published all of the trials together in one paper rather than publishing individually, so they put it all together from the very beginning. And I think it really makes sense in a pandemic setting.”
Dr. Weatherald is also conducting research on prone positioning in COVID-19 patients. In the time it took his team to enroll 400 patients, Dr. Li and colleagues had enrolled nearly 1200, he said. Incidentally, Dr. Weatherald’s data appear to confirm the conclusions from Dr. Li’s team, for the most part, Dr. Weatherald noted.
SOURCE: https://bit.ly/3jLzCtU and https://bit.ly/3hsyuKj The Lancet Respiratory Medicine, online August 20, 2021.
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