Moderate to severe acute hypoxaemic respiratory failure (AHRF) Respiratory
Conditions
Interventions
Participants are randomised to either:
1. Early airway pressure release ventilation (APRV)
2. Standard conventional lung protective invasive mechanical ventilation (no APRV)
Participants will be rand
Sponsors
University of Warwick
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 25/06/2025: 1. Age =18 years 2. Receiving invasive mechanical ventilation 3. Moderate to severe acute hypoxaemic respiratory failure, defined as a single measurement showing a PaO2/FiO2 ratio 48 hours _____ Previous inclusion criteria: 1. Age =18 years 2. Receiving invasive mechanical ventilation 3. Moderate to severe AHRF (PaO2/FiO2 48 hours
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 25/06/2025: 1. Receiving IMV =60 hours at the time of screening as will be unable to deliver early APRV 2. Primary reason for invasive mechanical ventilation is one of the following: 2.1. Asthma 2.2. Severe COPD 2.3. Pulmonary embolism (massive or sub-massive) (as cause of hypoxaemia is not primarily due to collapse of lung tissue) 2.4. Existing neuromuscular disease such as motor neurone disease, Guillain Barre or myasthenia gravis (as the cause of respiratory failure is not primarily lung-related) 3. Refractory shock (systolic blood pressure < 90 mmHg, despite fluid administration and vasoactive drugs)* 4. Severe hypercapnic respiratory acidosis (pH <7.20 on the arterial blood gas assessed for trial inclusion)* 5. Ongoing air leak (e.g. unresolved pneumothorax at time of screening)* 6. Traumatic brain injury with uncontrolled intracranial hypertension* 7. Likely death or treatment withdrawal in the next 24 hours 8. Home ventilation or home oxygen therapy prior to admission 9. Receiving, or decision to commence, ECMO in the next 24 hours *(patients can be recruited if this resolves and remain eligible) _____ Previous exclusion criteria: 1. Receiving IMV =60 hours at the time of screening as will be unable to deliver early APRV 2. Primary reason for invasive mechanical ventilation is one of the following: 2.1. Asthma 2.2. Severe COPD 2.3. Pulmonary embolism (massive or sub-massive) (as cause of hypoxaemia is not primarily due to collapse of lung tissue) 2.4. Existing neuromuscular disease such as motor neurone disease, Guillain Barre or myasthenia gravis (as the cause of respiratory failure is not primarily lung-related) 3. Refractory shock (systolic blood pressure < 90 mmHg, despite fluid administration and vasoactive drugs)* 4. Severe hypercapnic respiratory acidosis (pH <7.20 on the arterial blood gas assessed for trial inclusion)* 5. Ongoing air leak (e.g. unresolved pneumothorax at time of screening)* 6. Traumatic brain injury with uncontrolled intracranial hypertension* 7. Likely death or treatment withdrawal in the next 24 hours 8. Home ventilation or home oxygen therapy prior to admission *(patients can be recruited if this resolves and remain eligible)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 25/06/2025: Duration of mechanical ventilation (defined as the time from randomisation to first successful unassisted breathing or death) measured using data collected from site staff at the time of first successful unassisted breathing or death _____ Previous primary outcome measure: Duration of invasive mechanical ventilation (defined as the time from randomisation to first successful unassisted breathing or death) measured using data collected from site staff at the time of first successful unassisted breathing or death | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 25/06/2025: 1. All-cause mortality measured using data collected from site staff at 2 and 6 months 2. Time to first successful extubation 3. Need for reintubation prior to achieving first successful unassisted breathing 4. Use of non-invasive ventilation following extubation but prior to achieving first successful unassisted breathing 5. CCU and hospital length of stay measured using data collected from site staff at time of CCU and hospital discharge 6. Serious adverse events measured using data collected from site staff up to time of hospital discharge 7. Health-related quality of life measured using the 5-level EQ-5D version (EQ-5D-5L) at 2 and 6 months 8. Acute health care use measured using participant-completed resource use questionnaires and, if available, enriched using data obtained from site staff or linkage at 2 and 6 months 9. Within-trial cost-utility analysis from an NHS hospital care perspective using data collected from site staff and data obtained through linkage to routine datasets at 2 and 6 months _____ Previous secondary outcome measures: 1. All-cause mortality measured using data collected from site staff at 2 and 6 months 2. Time to first extubation measured using data collected from site staff at time of extubation 3. Reintubation measured using data collected from site staff at time of reintubation 4. Use of non-invasive ventilation following extubation measured using data collected from site staff at time of extubation 5. CCU and hospital length of stay measured using data collected from site staff at time of CCU and hospital discharge 6. Serious adverse events measured using data collected from site staff up to time of hospital discharge 7. Health-related quality of life measured using the 5-level EQ-5D version (EQ-5D-5L) at 2 and 6 months 8. Acute health care use measured using participant-completed resource use questionnaires and, if available, enriched using data obtained from site staff or | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Contacts
Public ContactJonathan Guck
Outcome results
None listed