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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

NCT04395807•Lund University

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

•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

Locations (1)

Helsingborg's Hospital

Helsingborg, Region Skane, Sweden

Key Dates

Start Date

June 3, 2020

Primary Completion Date

April 12, 2021

Completion Date

April 12, 2021

Last Updated

April 15, 2021

Enrollment

ACTUAL participants

Conditions

COVIDAcute Hypoxemic Respiratory Failure

Interventions

Helmet CPAP

DEVICE

HFNC

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 15, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Helmet CPAP Versus HFNC in COVID-19

Inclusion Criteria

Exclusion Criteria

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