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Awake prone positioning in patients with acute hypoxaemic respiratory failure not due to COVID-19: a multi-centre, pragmatic, allocation concealed, individual patient randomised, parallel group, open-label clinical trial (AWAKE-PRONE)
Lying face-down for at least eight hours a day could keep thousands of hospital patients off ventilators. Each year in the UK, over 60,000 adults receive invasive breathing support in intensive care, often suffering long-term physical and psychological harm. During the COVID-19 pandemic, studies showed that placing patients on their stomachs—awake prone positioning—reduced the need for intubation. But it remains unclear whether the same strategy works for the many patients with respiratory failure from other causes, such as pneumonia or sepsis. This trial will recruit 1,708 adults across NHS hospitals in England, Scotland, Northern Ireland, and Wales. Half will be asked to lie prone for a target of eight hours daily; the other half will receive standard care. The primary measure is whether patients need a breathing tube within 30 days. If the strategy proves effective, it could become a simple, low-cost intervention deployed immediately on hospital wards, reducing ICU admissions and improving long-term outcomes for tens of thousands of patients each year.
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RESEARCH QUESTION: In hospitalised adults with acute hypoxaemic respiratory failure not due to COVID-19 and who are deemed suitable for tracheal intubation, does an awake prone positioning strategy compared with standard care reduce tracheal intubation at 30-days? BACKGROUND: In the UK, over 60,000 adults each year receive invasive ventilation on an intensive care unit. Whilst this is a life-saving interventions, patients often experience long-term physical, psychological and social impacts on their lives. There is an urgent need to identify strategies that can be implemented easily and quickly to reduce the need for intubation. COVID-19 studies show that awake prone positioning reduces the need for tracheal intubation. AIM: To conduct a multi-centre, pragmatic, individual patient randomised, open-label, parallel group trial, and economic evaluation to determine the clinical and cost-effectiveness of an awake prone position strategy, compared with standard NHS care. OBJECTIVES: (1) Conduct an internal pilot study to confirm the feasibility of the large-scale multi-centre trial; (2) Determine the clinical effectiveness of awake prone positioning, in relation to requiring tracheal intubation, for hospitalised adults with hypoxaemic respiratory failure; (3) Estimate, in an integrated economic evaluation, the cost-effectiveness of an awake prone positioning strategy. METHODS: Setting: NHS acute hospitals (all acute and critical care settings) across England, Scotland, Northern Ireland and Wales. Randomisation: Allocation concealed, randomisation (1:1 ratio), stratified by hospital site. Inclusion criteria: Adult (age=18) hospitalised but not intubated; acute hypoxaemic respiratory failure (SpO2 = 94% whilst receiving =40% supplemental oxygen) not due to COVID-19; deemed suitable for tracheal intubation; patient willingness to attempt awake prone positioning. Health technologies being assessed: Awake prone positioning (target = 8 hours/day) versus usual care. Primary outcome: Incidence of tracheal intubation (from randomisation to 30 days). Key secondary outcomes: ICU/hospital stay, time to tracheal intubation, time to ICU admission, requirement and duration of non-invasive ventilation, survival status (up to 6-months) and quality of life (3-months, 6-months); safety. Economic outcomes: Incremental cost per quality-adjusted life year gained from the perspective of the NHS and personal social services (within-trial and life-time model estimates). Sample size: 1708 participants (90% power, 5% alpha, to detect 6% absolute difference in tracheal intubation). TIMELINE OF DELIVERY: 48 months: 6-months set-up; 8-months internal pilot; 22-months recruitment; 6-months follow-up; 6-months data analysis, reporting and dissemination. ANTICIPATED IMPACT AND DISSEMINATION: The study will provide definitive evidence for the most effective strategy for patients with acute hypoxaemic respiratory failure who are not been intubated. The findings will define future NHS and international practice. We will publish lay and professional summaries in written, audible and infographic styles. We will promote at public engagement events and develop informative, patient facing website material and leaflets. We will disseminate to clinicians through peer-reviewed publications, podcasts, blogs, conference presentations and social media. We will engage policy makers through our membership of key organisations
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