Acute Hypoxemic Respiratory FailureHONOURNCT05078034
HNFO With or Without Helmet NIV for Oxygenation Support in Acute Respiratory Failure Pilot RCT
A study testing Helmet Non-Invasive Ventilation (HNIV) and High Flow Nasal Oxygen in people with Acute Hypoxemic Respiratory Failure, run by Sunnybrook Health Sciences Centre at 11 sites in Canada.
Trial summary
This Randomized Control Trial will directly compare helmet non-invasive ventilation (NIV) combined with high flow nasal oxygen (HFNO) versus HFNO alone in patients with Acute Hypoxemic Respiratory Failure (AHRF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Hypoxemic Respiratory Failure
- What is being tested?
- Helmet Non-Invasive Ventilation (HNIV) and High Flow Nasal Oxygen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 11 sitesCanada
- Study dates
- 17 Mar 2022to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Intensive care unit admission (orders written)
- Age ≥18 years
- Hypoxemic acute respiratory failure for at least 1 hour and still present at time of screening for eligibility (symptom onset during last 14 days) with the following:
- Respiratory rate >21bpm or clinical evidence of increased work of breathing and
- Documented Hypoxemia defined as any one of:
- PaO2:FiO2 < 300 ii. If no arterial blood gas available, then SpO2:FiO2 < 315 iii. Oxygen saturation <98% on FiO2 >= 0.4 or higher by Venturi mask, TAVISH mask 10 Litres / minute, or any non-invasive oxygenation strategy
- Not already intubated or with tracheostomy
Who cannot join
- Already on HFNO or other non-invasive ventilation strategy at FiO2>=0.4 for the last 24 hours in the ICU.
- Immediate need for intubation (e.g., inadequate airway protection or refractory hypoxemia or cardiopulmonary arrest, massive hemoptysis, etc)
- Extubated in the ICU within past 72 hours
- Clinician deems that face mask NIV is indicated to treat a primary diagnosis of hypercapnic respiratory failure or acute congestive heart failure
- Known neuromuscular disease
- Patients being transitioned to Palliative care or unlikely to survive more than 24 hours
Show all 10Show fewer
- ICU discharge is planned or anticipated on the day of screening
- Previously enrolled in this trial
- Trauma patients who remain in a cervical spine collar at the time of recruitment or who have upper limb/torso fractures that would preclude them from safe application of the helmet
- Clinician decision that positive pressure to face and/or nasal pharynx is a contraindication (eg. Transphenoidal surgery, basal skull fracture etc.)
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Canada11 sites
University of Calgary
Calgary, Alberta, T2N 4N1
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
Hamilton Health Sciences- Juravinski
Hamilton, Ontario
Kingston General Hospital
Kingston, Ontario
London Health Sciences Centre
London, Ontario
Ottawa Hospital
Ottawa, Ontario, K1H 8L6
North York General Hospital
Toronto, Ontario, M2K 1E1
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Mount Sinai Hospital
Toronto, Ontario
University Health Network Toronto General
Toronto, Ontario
About this study
Official title: High-flow Nasal Oxygen With or Without Helmet Non-invasive Ventilation for Oxygenation Support in Acute Respiratory Failure (the HONOUR Pilot Trial)
This Randomized Control Trial will directly compare helmet non-invasive ventilation (NIV) combined with high flow nasal oxygen (HFNO) versus HFNO alone in patients with Acute Hypoxemic Respiratory Failure (AHRF).
Read the detailed description
This is a pilot multicentre, concealed, stratified, permuted block randomized controlled trial enrolling patients with AHRF who are admitted to the intensive care unit. Patients with imminent need for intubation, or a contraindication to study interventions will be excluded. Patients will be randomized to receive either (1) sessions of at least 12 hours per day of helmet NIV oxygen interspersed with HFNO or (2) HFNO alone over at least 2 calendar days. Participants will be followed to hospital discharge or 60 days, with an additional quality of life assessment via telephone interview 6 months after enrolment.
- Conditions
- Acute Hypoxemic Respiratory Failure
- Being tested
- Helmet Non-Invasive Ventilation (HNIV), High Flow Nasal Oxygen
- Keywords
- High Flow Nasal Oxygen, Helmet Non Invasive Ventilation
- 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 Non-Invasive Ventilation (HNIV)Device
Also called HNIV
HNIV will be connected to a ventilator by a conventional closed respiratory circuit. Sessions of HNIV will be delivered with PEEP targeting a minimum 12 hours/day. PEEP will be titrated according to patient comfort, work of breathing, and O2 saturation. Pressure support will be titrated to lowest level tolerated. Between HNIV sessions, patients will be supported with HFNO at the same required FiO2. Starting on study day 3, patients will be screened for discontinuation of HNIV. Once HNIV is stopped, patients will be transitioned to HFNO and then weaned from HFNO as tolerated.
High Flow Nasal OxygenDevice
Also called HFNO
HFNO will be provided. FiO2 will be titrated to achieve a target O2 saturation of 92-97%, and flows will be initiated at 50 litres/minute and titrated as per usual practice for comfort and oxygenation. Once the target O2 saturation is achieved, the FiO2 will be titrated to the minimal value to maintain this target saturation. HFNO will be provided continuously over a minimum of 2 calendar days. Starting on study day 3, patients will be weaned from HFNO as tolerated.
| Study group | Role | What they receive |
|---|---|---|
| HFNO | Active comparator | High Flow Nasal Oxygen alone Receives: Device: High Flow Nasal Oxygen |
| H-NIV | Active comparator | Helmet Non-Invasive ventilation for a minimum of 12 hours per day with HFNO between sessions Receives: Device: Helmet Non-Invasive Ventilation (HNIV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rates
Recruitment rate at different study sites
Measured: 2 years
Non-randomized Eligible Patients
Proportion of Eligible patients who are not randomized and reasons for this
Measured: 2 years
Adherence/Compliance to Oxygenation Strategy
Rate of adherence to the assigned oxygenation strategy (and crossover rates)
Measured: 2 years
Among patients requiring intubation in each group, the number who were intubated according to the pre-specified criteria
Adherence to pre-specified criteria for intubation in each group
Measured: 2 years
Time from ICU admission to randomization and initiation of treatment
Median time from ICU admission to randomization and initiation of the allocated treatment
Measured: 2 years
Secondary outcomes (10)
Number of participants in each group who need endotracheal intubation
Need for endotracheal intubation after randomization
Measured: 28 and 60 days
Duration of invasive mechanical ventilation after randomization up to 28 and 60 days
Duration of invasive mechanical ventilation after randomization up to 28 and 60 days
Measured: 28 and 60 days
Duration of non-invasive respiratory support after randomization up to 28 and 60 days
Duration of non-invasive mechanical ventilation after randomization up to 60 days
Measured: 60 days
ICU length of stay
days of ICU up to 28 days after randomization
Measured: 28 days
All cause mortality
All cause mortality to 60 days
Measured: 60 days
COVID-19 infection after hospitalization
diagnosis of COVID-19
Measured: 28 days
Health related quality of life
Health related quality of life as measured by telephone using the European Quality of Life Five Dimension (EQ-5D) tool, where a score of 1 means the patient has no problems, and a score of 5 mean the patient has extreme problems in the 5 dimensions.
Measured: 180 days
Mortality at 180 days
Mortality to 180 days
Measured: 180 days
Activities of Daily Living
Katz Index of Independence in Activities of Daily Living (ADL) where a high of 6 means the patient can perform the activities fully independently, and a low of 0 means the patient is fully dependent and unable to perform activities without assistance.
Measured: 180 days
Ventilator-Free Days to day 28, analyzed as an ordinal variable, with death = 0 days
Ventilator-Free Days to day 28, analyzed as an ordinal variable, with death = 0 days
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start17 Mar 2022
- Primary completionMar 2026 (estimated)
- Study completionAug 2026 (estimated)
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 Acute Hypoxemic Respiratory FailureStudies of the same condition, open and under way.
- 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
- Model description
- 1:1 randomized control trial
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Damon Scales, MD PhD FRCPC, Principal investigator, Sunnybrook Health Sciences CentreNiall Fergusson, MD FRCPC, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05078034
- Sponsor's protocol ID
- HONOUR (3693)
- Acronym
- HONOUR
- Status last verified
- Mar 2026
- First submitted
- 1 Oct 2021
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Angriman F, Ferreyro BL, Rochwerg B, Sklar M, Adhikari N, Bagshaw SM, Brochard L, Cuthbertson B, Del Sorbo L, Fowler R, Geagea A, Granton JT, Mehta S, Munshi L, Muscedere J, Nardi J, Parhar K, Pinto RL, Piquette D, Seely A, Slessarev M, Tobin S, Scales DC, Ferguson ND; HONOUR Investigators and the Canadian Critical Care Trials Group. High-flow nasal Oxygen with or without alternating helmet Non-invasive ventilation for Oxygenation sUpport in acute Respiratory failure (HONOUR): a protocol for a pilot randomised controlled trial. BMJ Open. 2025 Oct 27;15(10):e111526. doi: 10.1136/bmjopen-2025-111526.
PubMed 41145249
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-flow Nasal Oxygen With or Without Helmet Non-invasive Ventilation for Oxygenation Support in Acute Respiratory Failure (the HONOUR Pilot Trial)
- ClinicalTrials.gov ID
- NCT05078034
- Acronym / sponsor ID
- HONOUR / HONOUR (3693)
- Conditions
- Acute Hypoxemic Respiratory Failure
- Keywords
- High Flow Nasal Oxygen, Helmet Non Invasive Ventilation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 17 Mar 2022 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 14 Oct 2021 (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.
This Randomized Control Trial will directly compare helmet non-invasive ventilation (NIV) combined with high flow nasal oxygen (HFNO) versus HFNO alone in patients with Acute Hypoxemic Respiratory Failure (AHRF).
Detailed description
This is a pilot multicentre, concealed, stratified, permuted block randomized controlled trial enrolling patients with AHRF who are admitted to the intensive care unit. Patients with imminent need for intubation, or a contraindication to study interventions will be excluded. Patients will be randomized to receive either (1) sessions of at least 12 hours per day of helmet NIV oxygen interspersed with HFNO or (2) HFNO alone over at least 2 calendar days. Participants will be followed to hospital discharge or 60 days, with an additional quality of life assessment via telephone interview 6 months after enrolment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 randomized control trial
| Arm | Type | Receives |
|---|---|---|
| HFNO | Active comparator | Device: High Flow Nasal OxygenHigh Flow Nasal Oxygen alone |
| H-NIV | Active comparator | Device: Helmet Non-Invasive Ventilation (HNIV)Helmet Non-Invasive ventilation for a minimum of 12 hours per day with HFNO between sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Intensive care unit admission (orders written)
- Age ≥18 years
- Hypoxemic acute respiratory failure for at least 1 hour and still present at time of screening for eligibility (symptom onset during last 14 days) with the following:
- Not already intubated or with tracheostomy
Key exclusion criteria (10 listed)
- Already on HFNO or other non-invasive ventilation strategy at FiO2>=0.4 for the last 24 hours in the ICU.
- Immediate need for intubation (e.g., inadequate airway protection or refractory hypoxemia or cardiopulmonary arrest, massive hemoptysis, etc)
- Extubated in the ICU within past 72 hours
- Clinician deems that face mask NIV is indicated to treat a primary diagnosis of hypercapnic respiratory failure or acute congestive heart failure
- Known neuromuscular disease
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 Non-Invasive Ventilation (HNIV)Also: HNIVHNIV will be connected to a ventilator by a conventional closed respiratory circuit. Sessions of HNIV will be delivered with PEEP targeting a minimum 12 hours/day. PEEP will be titrated according to patient comfort, work of breathing, and O2 saturation. Pressure support will be titrated to lowest level tolerated. Between HNIV sessions, patients will be supported with HFNO at the same required FiO2. Starting on study day 3, patients will be screened for discontinuation of HNIV. Once HNIV is stopped, patients will be transitioned to HFNO and then weaned from HFNO as tolerated. | Device | H-NIV |
| High Flow Nasal OxygenAlso: HFNOHFNO will be provided. FiO2 will be titrated to achieve a target O2 saturation of 92-97%, and flows will be initiated at 50 litres/minute and titrated as per usual practice for comfort and oxygenation. Once the target O2 saturation is achieved, the FiO2 will be titrated to the minimal value to maintain this target saturation. HFNO will be provided continuously over a minimum of 2 calendar days. Starting on study day 3, patients will be weaned from HFNO as tolerated. | Device | HFNO |
Primary outcome
Recruitment Rates
Time frame: 2 years
Recruitment rate at different study sites
Non-randomized Eligible Patients
Time frame: 2 years
Proportion of Eligible patients who are not randomized and reasons for this
Adherence/Compliance to Oxygenation Strategy
Time frame: 2 years
Rate of adherence to the assigned oxygenation strategy (and crossover rates)
Among patients requiring intubation in each group, the number who were intubated according to the pre-specified criteria
Time frame: 2 years
Adherence to pre-specified criteria for intubation in each group
Time from ICU admission to randomization and initiation of treatment
Time frame: 2 years
Median time from ICU admission to randomization and initiation of the allocated treatment
10 secondary outcomes
Number of participants in each group who need endotracheal intubation
Time frame: 28 and 60 days
Duration of invasive mechanical ventilation after randomization up to 28 and 60 days
Time frame: 28 and 60 days
Duration of non-invasive respiratory support after randomization up to 28 and 60 days
Time frame: 60 days
ICU length of stay
Time frame: 28 days
All cause mortality
Time frame: 60 days
COVID-19 infection after hospitalization
Time frame: 28 days
Health related quality of life
Time frame: 180 days
Mortality at 180 days
Time frame: 180 days
Activities of Daily Living
Time frame: 180 days
Ventilator-Free Days to day 28, analyzed as an ordinal variable, with death = 0 days
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Derived from this study: PubMed 41145249Angriman F, Ferreyro BL, Rochwerg B, Sklar M, Adhikari N, Bagshaw SM, Brochard L, Cuthbertson B, Del Sorbo L, Fowler R, Geagea A, Granton JT, Mehta S, Munshi L, Muscedere J, Nardi J, Parhar K, Pinto RL, Piquette D, Seely A, Slessarev M, Tobin S, Scales DC, Ferguson ND; HONOUR Investigators and the Canadian Critical Care Trials Group. High-flow nasal Oxygen with or without alternating helmet Non-invasive ventilation for Oxygenation sUpport in acute Respiratory failure (HONOUR): a protocol for a pilot randomised controlled trial. BMJ Open. 2025 Oct 27;15(10):e111526. doi: 10.1136/bmjopen-2025-111526.
- Individual participant dataSharing planned: No
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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.
Damon Scales, MD PhD FRCPC principal investigator
Sunnybrook Health Sciences Centre
Niall Fergusson, MD FRCPC principal investigator
University Health Network, Toronto
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Helmet Non-Invasive Ventilation (HNIV) and High Flow Nasal Oxygen in people with Acute Hypoxemic Respiratory Failure, run by Sunnybrook Health Sciences Centre at 11 sites in Canada.
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 7 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Canada. 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?
This study is still under way. Results are not available in the source record yet.
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?
Recruitment Rates (time frame: 2 years). The study lists 5 primary outcomes in all. 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 NCT05078034, 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 16 Mar 2026.