An interventional study of Helmet CPAP and HFNC in COVID and Acute Hypoxemic Respiratory Failure, sponsored by Lund University. Terminated at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-15.
Sponsored by Lund University · Not applicable, Interventional, and Treatment
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.
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
1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.
This study's enrollment of 2 is below the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →Lund University is the lead sponsor of 230 studies on the registry; 37 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria (any of the following):
Helmet Continuous Positive Airway Pressure (CaStar hood for CPAP therapy by Starmed/Intersurgical) driven by high-flow blender (Bio-Med Devices).
Device: Helmet CPAP
High-Flow Nasal Cannula (OptiflowTM nasal high-flow interface) driven by AIRVO 2 humidification system (Fisher and Paykel)
Device: HFNC
Start-up air flow 40 L/min. Start-up PEEP 5 cmH2O. Max PEEP 20 cmH2O. Oxygen flow / FiO2% according to 92% SpO2 target. Titrations at physician's choice.
Start-up air flow 30 L/min. Max air flow 60 L/min. Oxygen flow / FiO2% according to 92% SpO2 target. Titrations at physician's choice.
Ventilator-Free Days (VFD)
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.
Time frame: 28 days
SpO2/FiO2-ratio
Peripheral oxygen saturation divided by fraction of inspired oxygen
Time frame: 1 hour after randomisation
Patient comfort
Visual scale (1-10)
Time frame: 24 hours after randomisation
Frequency of endotracheal intubation
Min 0, Max 1
Time frame: 28 days
Frequency of carbon dioxide rebreathing
Defined as pCO2 \> 6 kPa in a venous blood gas. Min 0, Max ∞
Time frame: 28 days
Days alive within
All-cause mortality. (180 days endpoint not in primary publication)
Time frame: 28 days and 180 days
Plan to share: Undecided
This study is terminated, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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