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.
Study 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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.)
Primary outcome measure(s)
Recruitment Rates — 2 years Recruitment rate at different study sites
Non-randomized Eligible Patients — 2 years Proportion of Eligible patients who are not randomized and reasons for this
Adherence/Compliance to Oxygenation Strategy — 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 — 2 years Adherence to pre-specified criteria for intubation in each group
Time from ICU admission to randomization and initiation of treatment — 2 years Median time from ICU admission to randomization and initiation of the allocated treatment
Trial sites (11)
Facility
City
Region
Status
University of Calgary
Calgary
Alberta
University of Alberta Hospital
Edmonton
Alberta
Hamilton Health Sciences- Juravinski
Hamilton
Ontario
Kingston General Hospital
Kingston
Ontario
London Health Sciences Centre
London
Ontario
Ottawa Hospital
Ottawa
Ontario
North York General Hospital
Toronto
Ontario
Sunnybrook Health Sciences Centre
Toronto
Ontario
St. Michael's Hospital
Toronto
Ontario
Mount Sinai Hospital
Toronto
Ontario
University Health Network Toronto General
Toronto
Ontario
More Sunnybrook Health Sciences Centre trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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