Acute respiratory failure (ARF) Respiratory Acute respiratory failure
Conditions
Interventions
A stand-alone randomised controlled pilot trial will be conducted. Patients with acute respiratory failure will be identified by paramedics responding to 999 ambulance call and enrolled in the study.
Sponsors
University of Sheffield
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults aged over 18 2. Acute respiratory failure defined as respiratory distress with peripheral oxygen saturation below BTS target levels (88% for patients with COPD, 94% for other conditions), despite supplemental oxygen
Exclusion criteria
Exclusion criteria: 1. The time difference between being able to start prehospital CPAP and being able to start in-hospital CPAP is expected to be less than 15 minutes 2. Age < 18 years 3. Known to have terminal illness 4. Known pre-existing lack of capacity (confirmed by relatives, carers or documentary evidence, such as Lasting Power of Attorney) 5. Documented not for resuscitation status 6. Acutely incapacitated patients with valid advanced directive declining non-invasive ventilation or participation in research 7. The patient has an oxygen alert card 8. Anticipated inability to apply CPAP (e.g. facial deformity) 9. Respiratory failure due to chest trauma 10. Contraindication to CPAP (suspected pneumothorax, respiratory arrest, epistaxis, vomiting, hypotension)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following feasibility outcomes will be reported descriptively together with their 95% confidence interval: 1. Recruitment rate per 100,000 population per year (target 8, i.e. 120 across 1.5 million) 2. Proportion recruited in error and classified as violations or deviations (target 0% and =10%) 3. Adherence to the allocation schedule (target =90%) 4. Adherence to treatment in the CPAP arm (target =75%) 5. Retention at 30 days (target =90%) 6. Data completeness (target =90%) | — |
Secondary
| Measure | Time frame |
|---|---|
| Summary estimates of effectiveness outcomes will also be reported with 95% confidence intervals across the whole trial population using an as randomised analysis: 1. Proportion surviving to 30 days 2. Proportion undergoing endotracheal intubation by 30 days 3. Proportion admitted to critical care at any point up to 30 days 4. Mean and median length of hospital stay 5. Mean EQ-5D-3L (measured for each participant at baseline and at the 30-day follow-up) 6. Key elements of health-care resource use up to 30 days | — |
Countries
England, United Kingdom
Contacts
Public ContactSam Keating
Outcome results
None listed