Clinical Trials Directory

Trials / Terminated

TerminatedNCT04395807

Helmet CPAP Versus HFNC in COVID-19

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

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
2 (actual)
Sponsor
Lund University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Conditions

Interventions

TypeNameDescription
DEVICEHelmet CPAPStart-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.
DEVICEHFNCStart-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.

Timeline

Start date
2020-06-03
Primary completion
2021-04-12
Completion
2021-04-12
First posted
2020-05-20
Last updated
2021-04-15

Locations

1 site across 1 country: Sweden

Source: ClinicalTrials.gov record NCT04395807. Inclusion in this directory is not an endorsement.