Acute hypoxaemic respiratory failure not due to COVID-19 Respiratory
Conditions
Interventions
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
Sponsors
University of Warwick
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of tracheal intubation within 30 days of randomisation, measured using hospital records. This does not include tracheal intubation where it is used only to facilitate an operation or procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| All secondary outcomes are measured to hospital discharge using hospital records unless specified: 1. Length of critical care stay (days), from randomisation 2. Length of hospital stay (days), from randomisation 3. Time to tracheal intubation (days) 4. Time to admission to critical care (hours/days) 5. Duration of non-invasive respiratory support (days) 6. New requirement for non-invasive respiratory support (yes/no) 7. Duration of mechanical ventilation during hospital stay (previously invasive ventilation) 8. Mortality, measured at hospital discharge, 2 months, and 6 months 9. Health-related quality of life measured using the EQ-5D-5L at 2 and 6 months 10. Pre-specified complications that occur between randomisation and 5 days (pressure ulcer/skin breakdown, dislodgement of central venous catheter, dislodgement of arterial catheter, dislodgement of peripheral venous catheter, dislodgement of urinary catheter, dislodgement of any other medical device, nausea requiring new treatment with anti-emetics, vomiting) | — |
Countries
England, Northern Ireland, United Kingdom, Wales
Contacts
Public ContactSharisse Alleyne
Outcome results
None listed