Helmet Continuous Positive Airway Pressure Versus High-Flow Nasal Cannula in COVID-19: A Pragmatic Randomised Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- COVID
- Sponsor
- Lund University
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Ventilator-Free Days (VFD)
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
Brief Summary
We aim to investigate whether the use of Continuous Positive Airway Pressure using a Helmet device (Helmet CPAP) will increase the number of days alive and free of ventilator within 28 days compared to the use of a High Flow Nasal Cannula (HFNC) in patients admitted to Helsingborg Hospital, Sweden, suffering from COVID-19 and an acute hypoxic respiratory failure.
Detailed Description
A detailed description can be found in the study protocol published in Trials in Dec 2020: Tverring, J., Åkesson, A. \& Nielsen, N. Helmet continuous positive airway pressure versus high-flow nasal cannula in COVID-19: a pragmatic randomised clinical trial (COVID HELMET). Trials 21, 994 (2020). https://doi.org/10.1186/s13063-020-04863-5
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Ventilator-Free Days (VFD)
Time Frame: 28 days
Number of days alive and free of mechanical ventilation within 28 days. Patients who die within 28 days will be counted as 0 VFD. Time in ventilator will be counted in hours and rounded to whole days.
Secondary Outcomes
- SpO2/FiO2-ratio(1 hour after randomisation)
- Patient comfort(24 hours after randomisation)
- Frequency of endotracheal intubation(28 days)
- Frequency of carbon dioxide rebreathing(28 days)
- Days alive within(28 days and 180 days)