HNFO With or Without Helmet NIV for Oxygenation Support in Acute Respiratory Failure Pilot RCT
- Conditions
- Acute Hypoxemic Respiratory Failure
- Interventions
- Device: Helmet Non-Invasive Ventilation (HNIV)Device: High Flow Nasal Oxygen
- Registration Number
- NCT05078034
- Lead Sponsor
- Sunnybrook Health Sciences Centre
- 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).
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
-
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
- 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.)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description H-NIV Helmet Non-Invasive Ventilation (HNIV) Helmet Non-Invasive ventilation for a minimum of 12 hours per day with HFNO between sessions HFNO High Flow Nasal Oxygen High Flow Nasal Oxygen alone
- Primary Outcome Measures
Name Time Method 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
Non-randomized Eligible Patients 2 years Proportion of Eligible patients who are not randomized and reasons for this
Recruitment Rates 2 years Recruitment rate at different study sites
Adherence/Compliance to Oxygenation Strategy 2 years Rate of adherence to the assigned oxygenation strategy (and crossover rates)
- Secondary Outcome Measures
Name Time Method Duration of non-invasive respiratory support after randomization up to 28 and 60 days 60 days Duration of non-invasive mechanical ventilation after randomization up to 60 days
ICU length of stay 28 days days of ICU up to 28 days after randomization
Number of participants in each group who need endotracheal intubation 28 and 60 days Need for endotracheal intubation after randomization
All cause mortality 60 days All cause mortality to 60 days
COVID-19 infection after hospitalization 28 days diagnosis of COVID-19
Health related quality of life 180 days 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.
Mortality at 180 days 180 days Mortality to 180 days
Duration of invasive mechanical ventilation after randomization up to 28 and 60 days 28 and 60 days Duration of invasive mechanical ventilation after randomization up to 28 and 60 days
Activities of Daily Living 180 days 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.
Ventilator-Free Days to day 28, analyzed as an ordinal variable, with death = 0 days 28 days Ventilator-Free Days to day 28, analyzed as an ordinal variable, with death = 0 days
Trial Locations
- Locations (11)
University of Calgary
🇨🇦Calgary, Alberta, Canada
Kingston General Hospital
🇨🇦Kingston, Ontario, Canada
University Health Network Toronto General
🇨🇦Toronto, Ontario, Canada
London Health Sciences Centre
🇨🇦London, Ontario, Canada
University of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada
Hamilton Health Sciences- Juravinski
🇨🇦Hamilton, 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