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
Device: Helmet CPAP
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.
Device: HFNC
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.
Inclusion Criteria (all of the following):
1. Age ≥ 18 years
2. Sars-Cov-2 found in the upper or lower respiratory tract by PCR during the current
disease episode
3. Peripheral oxygen saturation (SpO2) < 92 % despite conventional low-flow oxygen
therapy of at least 6 L /min for at least 15 min
4. A decision to initiate HFNC or Helmet CPAP by the attending ward physician
5. The patient has given written informed consent to participate.
Exclusion Criteria (any of the following):
1. Need for direct admission to the intensive care unit for mechanical ventilation
2. Unconsciousness or drowsiness
3. Pneumothorax
4. Carbon dioxide pressure (pCO2) > 6 kPa in venous blood gas (VBG)
5. Underlying chronic obstructive pulmonary disease stage III-IV
6. A decision not to participate
7. Inability to comprehend the study content and give informed consent
Helsingborg's Hospital
Helsingborg, Region Skane, Sweden
Jonas Tverring, MD, Principal Investigator
Lund University