Respiratory failure in patients with known or suspected COVID-19 (SARS-CoV-2 infection) Respiratory COVID-19 (SARS-CoV-2 infection)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 04/05/2021: 1. Adults =18 years 2. Hospital inpatient with suspected or proven COVID-19 3. FiO2 =0.4 and SpO2 =94% 4. Plan for escalation to intubation if needed Previous participant inclusion criteria: 1. Adults = 18 years 2. Admitted to hospital with suspected or proven COVID-19 3. On 40% oxygen (or greater) with SpO2 <94% 4. Plan for escalation to intubation if needed
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 04/05/2021: 1. Planned intubation and mechanical ventilation imminent within 1 hour 2. Known or clinically apparent pregnancy 3. Any absolute contraindication to CPAP or HFNO 4. Decision not to intubate due to ceiling of treatment or withdrawal of treatment anticipated 5. Equipment for both CPAP and HFNO not available Previous participant exclusion criteria: 1. Planned intubation and mechanical ventilation imminent within 1 hour 2. Known or clinically apparent pregnancy 3. Any absolute contraindication to CPAP or HFNO 4. Decision not to intubate due to ceiling of treatment or withdrawal of care anticipated 5. Equipment for both CPAP and HFNO not available
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite outcome comprising tracheal intubation or mortality within 30 days. Mortality will be reported from hospital records up until discharge and tracked after discharge. Intubation will be obtained from hospital data. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 04/05/2021: All outcome measures are assessed at up to 30-days or hospital discharge, whichever is later, and obtained from hospital records unless otherwise specified. 1. Intubation rate 2. Time to intubation 3. Time to death (mortality), obtained from hospital record or other source 4. Mortality in critical care (level 2/3) 5. Mortality during hospital stay 6. Mortality at 30 days, obtained from hospital record or other source 7. Length of stay in critical care (level 2/3) 8. Length of stay in hospital 9. Duration of invasive ventilation 10. Admission to ICU Previous secondary outcome measures: All outcome measures are assessed at up to 30-days or hospital discharge, whichever is later, and obtained from hospital records unless otherwise specified. 1. Intubation rate 2. Time to intubation 3. Time to death (mortality), obtained from hospital record or other source 4. Mortality in critical care (level 2/3) 5. Mortality during hospital stay 6. Mortality at 30 days, obtained from hospital record or other source 7. Length of stay in critical care (level 2/3) 8. Length of stay in hospital | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales