Awake prone positioning in non-intubated adults with respiratory failure

CoReCCT: The Awake Prone Study: Awake prone positioning in patients with acute hypoxaemic respiratory failure not due to COVID-19: A randomised controlled trial

Registry ID
ISRCTN63784375
Source registry
ISRCTN
Status
Recruiting
Study type
INTERVENTIONAL
Sponsor
University of Warwick
Enrollment
1708
Start date
2025-02-03
Completion date
2027-12-31
Last update
2026-08-17

Conditions

Summary

Acute hypoxaemic respiratory failure not due to COVID-19

Detailed description

In the intervention arm, participants will receive awake prone positioning over a maximum of 5 days/120 hours from randomisation. The target daily duration for awake prone positioning is ≥8 hours per 24-hour period. This may be achieved through a single long period of awake prone positioning or several shorter periods. The researchers expect any shorter period to last at least 1 hour. Each day, they will record the amount of time that an individual has spent in the awake prone position (full-prone or 3/4 prone) in the preceding 24 hours. Participants will lie in a prone position as long and frequently as feasible, as soon as possible after randomisation. The intervention will continue until one of the following criteria is met: 1. 120 hours from randomisation 2. Tracheal intubation 3. Participant recovery 4. Participant decision to stop intervention 5. Development of contraindication to awake prone positioning 6. Participant transferred to a care setting where intervention could not be delivered 7. Participant transferred to another hospital In the control group, participants will receive standard care, which does not include awake prone positioning.

Interventions

Inclusion criteria

Current inclusion criteria as of 28/07/2025: 1. Adult (age >18 years) hospitalised patient who is not intubated 2. Acute hypoxaemic respiratory failure which has required treatment with 40% oxygen or more for at least 1 hour 3. Deemed suitable for tracheal intubation in the event of physiological deterioration Previous inclusion criteria: 1. Adult (age >18 years) hospitalised patient who is not intubated 2. Acute hypoxaemic respiratory failure, defined as sustained SpO2 ≤94% whilst receiving ≥40% supplemental oxygen 3. Deemed suitable for tracheal intubation in the event of physiological deterioration

Exclusion criteria

1. Hypoxaemia fully explained by acute pulmonary oedema due to heart failure 2. Patient unwilling to attempt awake prone positioning 3. Contraindication to awake prone positioning 4. COVID-19 pneumonitis as primary cause of respiratory failure 5. Invasive mechanical ventilation during current hospital admission (except where provided only to facilitate a procedure or operation)

Locations

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