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

Primary Purpose

COVID, Acute Hypoxemic Respiratory Failure

Status
Terminated
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Helmet CPAP
HFNC
Sponsored by
Lund University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Helsingborg's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Helmet CPAP

HFNC

Arm Description

Helmet Continuous Positive Airway Pressure (CaStar hood for CPAP therapy by Starmed/Intersurgical) driven by high-flow blender (Bio-Med Devices).

High-Flow Nasal Cannula (OptiflowTM nasal high-flow interface) driven by AIRVO 2 humidification system (Fisher and Paykel)

Outcomes

Primary Outcome Measures

Ventilator-Free Days (VFD)
Number of days alive and free of mechanical ventilation within 28 days. Patients who die within 28 days will be counted as 0 VFD. Time in ventilator will be counted in hours and rounded to whole days.

Secondary Outcome Measures

SpO2/FiO2-ratio
Peripheral oxygen saturation divided by fraction of inspired oxygen
Patient comfort
Visual scale (1-10)
Frequency of endotracheal intubation
Min 0, Max 1
Frequency of carbon dioxide rebreathing
Defined as pCO2 > 6 kPa in a venous blood gas. Min 0, Max ∞
Days alive within
All-cause mortality. (180 days endpoint not in primary publication)

Full Information

First Posted
May 18, 2020
Last Updated
April 12, 2021
Sponsor
Lund University
Collaborators
Region Skane
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1. Study Identification

Unique Protocol Identification Number
NCT04395807
Brief Title
Helmet CPAP Versus HFNC in COVID-19
Acronym
COVID HELMET
Official Title
Helmet Continuous Positive Airway Pressure Versus High-Flow Nasal Cannula in COVID-19: A Pragmatic Randomised Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Terminated
Why Stopped
Few eligible patients at study start Patients received HFNC prior to intermediate care ward admission NIV was locally considered a step-up therapy to HFNC Full-face masks replaced the Helmet interface as local NIV standard
Study Start Date
June 3, 2020 (Actual)
Primary Completion Date
April 12, 2021 (Actual)
Study Completion Date
April 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lund University
Collaborators
Region Skane

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID, Acute Hypoxemic Respiratory Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Helmet CPAP
Arm Type
Active Comparator
Arm Description
Helmet Continuous Positive Airway Pressure (CaStar hood for CPAP therapy by Starmed/Intersurgical) driven by high-flow blender (Bio-Med Devices).
Arm Title
HFNC
Arm Type
Active Comparator
Arm Description
High-Flow Nasal Cannula (OptiflowTM nasal high-flow interface) driven by AIRVO 2 humidification system (Fisher and Paykel)
Intervention Type
Device
Intervention Name(s)
Helmet CPAP
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
HFNC
Intervention Description
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.
Primary Outcome Measure Information:
Title
Ventilator-Free Days (VFD)
Description
Number of days alive and free of mechanical ventilation within 28 days. Patients who die within 28 days will be counted as 0 VFD. Time in ventilator will be counted in hours and rounded to whole days.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
SpO2/FiO2-ratio
Description
Peripheral oxygen saturation divided by fraction of inspired oxygen
Time Frame
1 hour after randomisation
Title
Patient comfort
Description
Visual scale (1-10)
Time Frame
24 hours after randomisation
Title
Frequency of endotracheal intubation
Description
Min 0, Max 1
Time Frame
28 days
Title
Frequency of carbon dioxide rebreathing
Description
Defined as pCO2 > 6 kPa in a venous blood gas. Min 0, Max ∞
Time Frame
28 days
Title
Days alive within
Description
All-cause mortality. (180 days endpoint not in primary publication)
Time Frame
28 days and 180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria (all of the following): Age ≥ 18 years Sars-Cov-2 found in the upper or lower respiratory tract by PCR during the current disease episode Peripheral oxygen saturation (SpO2) < 92 % despite conventional low-flow oxygen therapy of at least 6 L /min for at least 15 min A decision to initiate HFNC or Helmet CPAP by the attending ward physician The patient has given written informed consent to participate. Exclusion Criteria (any of the following): Need for direct admission to the intensive care unit for mechanical ventilation Unconsciousness or drowsiness Pneumothorax Carbon dioxide pressure (pCO2) > 6 kPa in venous blood gas (VBG) Underlying chronic obstructive pulmonary disease stage III-IV A decision not to participate Inability to comprehend the study content and give informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonas Tverring, MD
Organizational Affiliation
Lund University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helsingborg's Hospital
City
Helsingborg
State/Province
Region Skane
ZIP/Postal Code
252 23
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33272319
Citation
Tverring J, Akesson A, Nielsen N. Helmet continuous positive airway pressure versus high-flow nasal cannula in COVID-19: a pragmatic randomised clinical trial (COVID HELMET). Trials. 2020 Dec 3;21(1):994. doi: 10.1186/s13063-020-04863-5.
Results Reference
derived

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Helmet CPAP Versus HFNC in COVID-19

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