A ‘gentleman’s agreement’ allowed an Irish consultant to create a worldwide study that has profound implications for critically ill Covid-19 patients, as well as changing the way and speed with which international trials are conducted
An Irish doctor initiated a landmark international study which found that critically ill Covid-19 patients are less likely to die — or to require invasive ventilation — if lying prone on their stomachs while receiving oxygen.
Dr Bairbre McNicholas, an Intensive Care Consultant at University Hospital Galway and ‘honary Senior Lecturer at NUI Galway was part of an international team which assessed the impact of a technique, known as ‘awake-prone positioning’, in hospitals across six countries, on 1,121 coronavirus patients who required advanced breathing support.
The findings, which were were published last month in The Lancet Respiratory Medicine, include:
- Awake prone positioning reduces death and the need for invasive intubation in patients with severe Covid-19 who require high flow nasal cannula oxygen.
- The technique is safe and well tolerated by patients.
- Blood oxygen levels are significantly improved in patients who adopt awake prone positioning.
- The longer patients can sustain being in prone positioning, the greater the success of the treatment and the less likely the need for invasive mechanical ventilation.
- Given the scarcity of ventilators and oxygen therapy, particularly in low income countries, this study provides welcome data on the efficacy of awake prone positioning which will ensure that the low-cost strategy to invasive mechanical ventilation is supported as a treatment strategy.
But the very nature of how the trial was initiated, shared, and conducted was ground-breaking in terms of the speed and co-operation of international medics.
“A layer of red tape was removed,” said Dr McNicholas. “You can do many things in an ICU that help, and you can recommend it to others, but until you have a published clinical trial, the treatment won’t be given to every patient across the world.”
Usually, a clinical trial will take years to get off the ground, have one main centre, and a complicated procedural order which must be maintained throughout.
In this case, Dr McNicholas enlisted other medical centres to simultaneously conduct parallel research, but research that could be tweaked as it progressed, if needed.
The result is a not just a success in terms of proving the efficacy of the practice of awake-prone positioning, but also of the value of undertaking clinical trials with this methodology, especially in the area of rare diseases.
Dr McNicholas said: “Providing an evidence base for what we do in the ICU is critical so that we support and implement recommendations that work. This study shows that clinical trials can be scaled up and done properly and efficiently during a pandemic. It demonstrates what we can achieve when we work together.”