HNFO With or Without Helmet NIV for Oxygenation Support in Acute Respiratory Failure Pilot RCT

NCT05078034 | Active Not Recruiting DMC

• 1 other identifier: HONOUR (3693)
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 11

Brief 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).

Conditions

Acute Hypoxemic Respiratory Failure

Keywords

High Flow Nasal Oxygen; Helmet Non Invasive Ventilation

Outcome Measures

Primary Outcomes (5)

• Recruitment Rates

  Recruitment rate at different study sites

  2 years

• Non-randomized Eligible Patients

  Proportion of Eligible patients who are not randomized and reasons for this

  2 years

• Adherence/Compliance to Oxygenation Strategy

  Rate of adherence to the assigned oxygenation strategy (and crossover rates)

  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

  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

  2 years

Secondary Outcomes (10)

• Number of participants in each group who need endotracheal intubation

  28 and 60 days

• Duration of invasive mechanical ventilation after randomization up to 28 and 60 days

  28 and 60 days

• Duration of non-invasive respiratory support after randomization up to 28 and 60 days

  60 days

• ICU length of stay

  28 days

• All cause mortality

  60 days

Study Arms (2)

HFNO

ACTIVE COMPARATOR

High Flow Nasal Oxygen alone

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

Device: Helmet Non-Invasive Ventilation (HNIV)

Interventions

High Flow Nasal Oxygen DEVICE

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.

Also known as: HFNO

HFNO

Helmet Non-Invasive Ventilation (HNIV) DEVICE

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.

Also known as: HNIV

H-NIV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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
• Not already intubated or with tracheostomy

You may not qualify if:

• 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
• 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.)

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (11)

University of Calgary

Calgary, Alberta, T2N 4N1, Canada

Location

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Hamilton Health Sciences- Juravinski

Hamilton, Ontario, Canada

Location

Kingston General Hospital

Kingston, Ontario, Canada

Location

London Health Sciences Centre

London, Ontario, Canada

Location

Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

North York General Hospital

Toronto, Ontario, M2K 1E1, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, Canada

Location

University Health Network Toronto General

Toronto, Ontario, Canada

Location

Related Publications (1)

• 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.

  PMID: 41145249 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Damon Scales, MD PhD FRCPC

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

• Niall Fergusson, MD FRCPC

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1:1 randomized control trial

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: October 14, 2021
• Study Start: March 17, 2022
• Primary Completion: March 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (11)