Comparing helmet ventilation with high flow nasal oxygen for respiratory failure

High-flow Nasal Oxygen With or Without Helmet Non-invasive Ventilation for Oxygenation Support in Acute Respiratory Failure (the HONOUR Pilot Trial)

This study is testing whether using a special helmet for breathing support along with high flow nasal oxygen helps people with severe breathing problems do better than just using high flow nasal oxygen alone.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sunnybrook Health Sciences Centre (Academic / other)
• Locations: 11 sites (Calgary, Alberta and 10 other locations)
• Trial ID: NCT05078034 on ClinicalTrials.gov

What this trial studies

This pilot randomized controlled trial aims to compare the effectiveness of helmet non-invasive ventilation (NIV) combined with high flow nasal oxygen (HFNO) against HFNO alone in patients suffering from acute hypoxemic respiratory failure (AHRF). Patients admitted to the intensive care unit will be randomly assigned to receive either the combined treatment or HFNO alone for a minimum of two days. The study will monitor participants until hospital discharge or for 60 days, with follow-up quality of life assessments conducted via telephone six months post-enrollment. The trial seeks to determine which approach provides better oxygenation support in this critical patient population.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who are admitted to the ICU with acute hypoxemic respiratory failure.

Not a fit: Patients who are already intubated or have an immediate need for intubation will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve oxygenation support strategies for patients with acute respiratory failure, potentially reducing the need for intubation.

How similar studies have performed: Other studies have explored non-invasive ventilation strategies, but this specific combination of helmet NIV and HFNO is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Intensive care unit admission (orders written)
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:

1. Already on HFNO or other non-invasive ventilation strategy at FiO2\>=0.4 for the last 24 hours in the ICU.
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.)

Where this trial is running

Calgary, Alberta and 10 other locations

• University of Calgary — Calgary, Alberta, Canada (Recruiting)
• University of Alberta Hospital — Edmonton, Alberta, Canada (Recruiting)
• Hamilton Health Sciences- Juravinski — Hamilton, Ontario, Canada (Recruiting)
• Kingston General Hospital — Kingston, Ontario, Canada (Recruiting)
• London Health Sciences Centre — London, Ontario, Canada (Recruiting)
• Ottawa Hospital — Ottawa, Ontario, Canada (Recruiting)
• North York General Hospital — Toronto, Ontario, Canada (Recruiting)
• Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (Recruiting)
• St. Michael's Hospital — Toronto, Ontario, Canada (Recruiting)
• Mount Sinai Hospital — Toronto, Ontario, Canada (Recruiting)
• University Health Network Toronto General — Toronto, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Damon Scales, MD PhD FRCPC — Sunnybrook Health Sciences Centre
• Study coordinator: Damon Scales, MD PhD FRCPC

Conditions Acute Hypoxemic Respiratory Failure; High Flow Nasal Oxygen; Helmet Non Invasive Ventilation