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Helmet CPAP Versus HFNC in COVID-19 (COVID HELMET)

L

Lund University

Status

Terminated

Conditions

Acute Hypoxemic Respiratory Failure
COVID

Treatments

Device: Helmet CPAP
Device: HFNC

Study type

Interventional

Funder types

Other

Identifiers

NCT04395807
COVID HELMET

Details and patient eligibility

About

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.

Full 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

Enrollment

2 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

2 participants in 2 patient groups

Helmet CPAP
Active Comparator group
Description:
Helmet Continuous Positive Airway Pressure (CaStar hood for CPAP therapy by Starmed/Intersurgical) driven by high-flow blender (Bio-Med Devices).
Treatment:
Device: Helmet CPAP
HFNC
Active Comparator group
Description:
High-Flow Nasal Cannula (OptiflowTM nasal high-flow interface) driven by AIRVO 2 humidification system (Fisher and Paykel)
Treatment:
Device: HFNC

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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