HNFO With or Without Helmet NIV for Oxygenation Support in Acute Respiratory Failure Pilot RCT
NCT ID: NCT05078034
Last Updated: 2024-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2022-03-17
2025-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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HFNO
High Flow Nasal Oxygen alone
High Flow Nasal Oxygen
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.
H-NIV
Helmet Non-Invasive ventilation for a minimum of 12 hours per day with HFNO between sessions
Helmet Non-Invasive Ventilation (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.
Interventions
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Helmet Non-Invasive Ventilation (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 Oxygen
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age ≥18 years
3. 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:
1. Respiratory rate \>21bpm or clinical evidence of increased work of breathing and
2. Documented Hypoxemia defined as any one of:
i. 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
4. Not already intubated or with tracheostomy
Exclusion Criteria
2. Immediate need for intubation (e.g., inadequate airway protection or refractory hypoxemia or cardiopulmonary arrest, massive hemoptysis, etc)
3. Extubated in the ICU within past 72 hours
4. Clinician deems that face mask NIV is indicated to treat a primary diagnosis of hypercapnic respiratory failure or acute congestive heart failure
5. Known neuromuscular disease
6. Patients being transitioned to Palliative care or unlikely to survive more than 24 hours
7. ICU discharge is planned or anticipated on the day of screening
8. Previously enrolled in this trial
9. 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
10. Clinician decision that positive pressure to face and/or nasal pharynx is a contraindication (eg. Transphenoidal surgery, basal skull fracture etc.)
18 Years
ALL
No
Sponsors
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Sunnybrook Health Sciences Centre
OTHER
Responsible Party
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Principal Investigators
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Damon Scales, MD PhD FRCPC
Role: PRINCIPAL_INVESTIGATOR
Sunnybrook Health Sciences Centre
Niall Fergusson, MD FRCPC
Role: PRINCIPAL_INVESTIGATOR
University Health Network, Toronto
Locations
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University of Calgary
Calgary, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
Hamilton Health Sciences- Juravinski
Hamilton, Ontario, Canada
Kingston General Hospital
Kingston, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Ottawa Hospital
Ottawa, Ontario, Canada
North York General Hospital
Toronto, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
University Health Network Toronto General
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Bram Rochwerg, MD
Role: primary
John Muscedere, MD
Role: primary
Marat Slessarev, MD
Role: primary
Damon Scales, MD
Role: primary
Laveena Munshi, MD
Role: primary
Lorenzo Del Sorbo, MD
Role: primary
References
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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.
Other Identifiers
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HONOUR (3693)
Identifier Type: -
Identifier Source: org_study_id
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