Helmet CPAP Versus HFNC in COVID-19
- Conditions
- COVIDAcute Hypoxemic Respiratory Failure
- Registration Number
- NCT04395807
- Lead Sponsor
- Lund University
- 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 2
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Ventilator-Free Days (VFD) 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 Outcome Measures
Name Time Method SpO2/FiO2-ratio 1 hour after randomisation Peripheral oxygen saturation divided by fraction of inspired oxygen
Patient comfort 24 hours after randomisation Visual scale (1-10)
Frequency of endotracheal intubation 28 days Min 0, Max 1
Frequency of carbon dioxide rebreathing 28 days Defined as pCO2 \> 6 kPa in a venous blood gas. Min 0, Max ∞
Days alive within 28 days and 180 days All-cause mortality. (180 days endpoint not in primary publication)
Trial Locations
- Locations (1)
Helsingborg's Hospital
🇸🇪Helsingborg, Region Skane, Sweden
Helsingborg's Hospital🇸🇪Helsingborg, Region Skane, Sweden