Official Title
Helmet Continuous Positive Airway Pressure Versus High-Flow Nasal Cannula in COVID-19: A Pragmatic Randomised Clinical Trial
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

Terminated
COVID
Acute Hypoxemic Respiratory Failure

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.

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Sweden
Locations

Helsingborg's Hospital
Helsingborg, Region Skane, Sweden

Jonas Tverring, MD, Principal Investigator
Lund University

NCT Number
MeSH Terms
Respiratory Insufficiency