COVIDCOVID HELMETNCT04395807
Helmet CPAP Versus HFNC in COVID-19
A study testing Helmet CPAP and HFNC in people with COVID and Acute Hypoxemic Respiratory Failure, run by Lund University at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID, Acute Hypoxemic Respiratory Failure
- What is being tested?
- Helmet CPAP and HFNC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteSweden
- Study dates
- 3 Jun 2020to 12 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Helmet Continuous Positive Airway Pressure Versus High-Flow Nasal Cannula in COVID-19: A Pragmatic Randomised Clinical Trial
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.
Read the 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
- COVID, Acute Hypoxemic Respiratory Failure
- Being tested
- Helmet CPAP, HFNC
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Helmet CPAPDevice
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.
HFNCDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Helmet CPAP | Active comparator | Helmet Continuous Positive Airway Pressure (CaStar hood for CPAP therapy by Starmed/Intersurgical) driven by high-flow blender (Bio-Med Devices). Receives: Device: Helmet CPAP |
| HFNC | Active comparator | High-Flow Nasal Cannula (OptiflowTM nasal high-flow interface) driven by AIRVO 2 humidification system (Fisher and Paykel) Receives: Device: HFNC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Secondary outcomes (5)
SpO2/FiO2-ratio
Peripheral oxygen saturation divided by fraction of inspired oxygen
Measured: 1 hour after randomisation
Patient comfort
Visual scale (1-10)
Measured: 24 hours after randomisation
Frequency of endotracheal intubation
Min 0, Max 1
Measured: 28 days
Frequency of carbon dioxide rebreathing
Defined as pCO2 > 6 kPa in a venous blood gas. Min 0, Max ∞
Measured: 28 days
Days alive within
All-cause mortality. (180 days endpoint not in primary publication)
Measured: 28 days and 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start3 Jun 2020
- Primary completion12 Apr 2021
- Study completion12 Apr 2021
Why it stopped: 1. Few eligible patients at study start 2. Patients received HFNC prior to intermediate care ward admission 3. NIV was locally considered a step-up therapy to HFNC 4. Full-face masks replaced the Helmet interface as local NIV standard
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVIDStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- Region Skane
- Responsible party
- Sponsor
- Investigators
- Jonas Tverring, MD, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04395807
- Sponsor's protocol ID
- COVID HELMET
- Acronym
- COVID HELMET
- Status last verified
- Apr 2021
- First submitted
- 18 May 2020
- Last updated
- 15 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33272319
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helmet Continuous Positive Airway Pressure Versus High-Flow Nasal Cannula in COVID-19: A Pragmatic Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT04395807
- Acronym / sponsor ID
- COVID HELMET / COVID HELMET
- Conditions
- COVID, Acute Hypoxemic Respiratory Failure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 1. Few eligible patients at study start 2. Patients received HFNC prior to intermediate care ward admission 3. NIV was locally considered a step-up therapy to HFNC 4. Full-face masks replaced the Helmet interface as local NIV standard
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- Region Skane
- Study start
- 3 Jun 2020 (actual)
- Primary completion
- 12 Apr 2021 (actual)
- Study completion
- 12 Apr 2021 (actual)
- First posted
- 20 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Helmet CPAP | Active comparator | Device: Helmet CPAPHelmet Continuous Positive Airway Pressure (CaStar hood for CPAP therapy by Starmed/Intersurgical) driven by high-flow blender (Bio-Med Devices). |
| HFNC | Active comparator | Device: HFNCHigh-Flow Nasal Cannula (OptiflowTM nasal high-flow interface) driven by AIRVO 2 humidification system (Fisher and Paykel) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Helmet 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. | Device | Helmet CPAP |
| HFNCStart-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. | Device | HFNC |
Primary outcome
Ventilator-Free Days (VFD)
Time frame: 28 days
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.
5 secondary outcomes
SpO2/FiO2-ratio
Time frame: 1 hour after randomisation
Patient comfort
Time frame: 24 hours after randomisation
Frequency of endotracheal intubation
Time frame: 28 days
Frequency of carbon dioxide rebreathing
Time frame: 28 days
Days alive within
Time frame: 28 days and 180 days
Results and safety
The study was stopped early (reason given: 1. Few eligible patients at study start 2. Patients received HFNC prior to intermediate care ward admission 3. NIV was locally considered a step-up therapy to HFNC 4. Full-face masks replaced the Helmet interface as local NIV standard). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2021.
- Derived from this study: PubMed 33272319Tverring 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonas Tverring, MD principal investigator
Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Helmet CPAP and HFNC in people with COVID and Acute Hypoxemic Respiratory Failure, run by Lund University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 1. Few eligible patients at study start 2. Patients received HFNC prior to intermediate care ward admission 3. NIV was locally considered a step-up therapy to HFNC 4. Full-face masks replaced the Helmet interface as local NIV standard). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilator-Free Days (VFD) (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04395807, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2021.