Protocol v5.0 03/07/2025 Rotherham Principal Investigator: Professor Anil Hormis Research team member: Dr Katie Webb
research topic:
Effect of awake prone positioning on need for tracheal intubation (not due to COVID-19)
trial groups:
Intervention: Conscious prone position for ≥8hrs / day Control: Usual care (semi recumbent with 30⁰-90⁰ head elevation or slight side tilt)
inclusion criteria:
Hospitalised adult (aged ≥18 years) who is not intubated—does not need to be within critical care patients elsewhere can also be recruited
Acute respiratory failure (sustained SpO2≤94% on ≥40% oxygen)
Deemed suitable for intubation if deterioration
exclusion criteria:
Hypoxaemia caused by pulmonary oedema secondary to heart failure
Unwilling to attempt awake prone positioning
COVID-19 pneumonitis as the main cause of respiratory failure
Contraindication to awake prone positioning
Previously ventilated during current admission (except to facilitate a procedure or operation)
consent:
Formal consent is required for Awake Prone trial enrolment/randomisation. If you think your patient is in any way eligible please contact the research team who will review the full inclusion/exclusion criteria and approach for consent.
running the intervention:
If randomised to the intervention group the patient is advised to lay prone position over a maximum of 5 days/120 hours from randomisation. The daily target is for awake prone positioning for ≥8hrs / day this can be a single long period or several shorter periods. Participants will lie prone as long as frequently as feasible. A beside patient booklet for positioning advice and a chart for nursing staff to record timings will be provided. The intervention stops after : 120 hours, intubation, or patient deemed recovered.