Study Summary

Awake Prone is a a multi-centre, pragmatic, individual patient randomised, open-label, parallel group study to evaluate the clinical- and cost-effectiveness of awake prone positioning in patients with acute hypoxaemic respiratory failure.

Hospitalised adult patients with acute hypoxaemic respiratory not due to COVID-19, and who are deemed suitable for tracheal intubation in the event of physiological deterioration, will be randomised in a 1:1 ratio to either awake prone positioning or standard care. The study will include an internal pilot (8 months duration) during which we will test the detailed trial procedures, data collection and confirm the feasibility of recruitment. Patients will be followed up for 6 months post-randomisation to assess their quality of life and to collect cost data for the economic evaluation.

The trial will be conducted across at least 60 hospitals in the UK.

The trial will incorporate a study within a trial to explore strategies for monitoring treatment adherence.

Primary Objective

The primary objective of the study is to evaluate the clinical effectiveness of awake prone positioning in non-intubated adults with acute hypoxaemic respiratory failure not due to COVID-19, measured by our primary outcome of tracheal intubation within 30 days.

 

Secondary Objective

Secondary objectives of the study are to:

• Evaluate the effect of awake prone positioning in non-intubated adults with acute hypoxaemic respiratory failure not due to COVID-19 on mortality, quality of life, and hospital length of stay.
• To determine the cost-effectiveness of awake prone positioning in non-intubated adults with acute hypoxaemic respiratory failure not due to COVID-19

Primary Outcome Measure

The primary outcome is the incidence of tracheal intubation within 30 days of randomisation. This does not include tracheal intubation where it is used only to facilitate an operation or procedure.

Secondary Outcome Measures

• Length of critical care stay (days), from randomisation
• Length of hospital stay (days), from randomisation
• Time to tracheal intubation (days)
• Time to admission to critical care (hours/days)
• Duration of non-invasive respiratory support (days)
• New requirement for non-invasive respiratory support (yes/no)
• Duration of invasive ventilation during hospital stay
• Mortality (hospital discharge/ 2 months/ 6 months)
• Health related quality of life- EQ-5D-5L (2 months/ 6 months)
• Pre-specified complications that occur between randomisation and 5 days*

Eligibility Criteria

Patients are eligible to be included in the trial if they meet all the inclusion criteria and none of the exclusion criteria:

Inclusion Criteria

• Adult (age >18 years) hospitalised patient who is not intubated
• Acute hypoxaemic respiratory failure, defined as sustained SpO₂ ≤ 94% whilst receiving ≥40% supplemental oxygen
• Deemed suitable for tracheal intubation in event of physiological deterioration

Exclusion Criteria

• Hypoxaemia fully explained by acute pulmonary oedema due to heart failure
• Patient unwilling to attempt awake prone positioning
• Contraindication to awake prone positioning
• COVID-19 pneumonitis as primary cause of respiratory failure
• Invasive mechanical ventilation during current hospital admission (except where provided only to facilitate a procedure or operation)