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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
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.
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.
University of Calgary
Calgary, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
Hamilton Health Sciences- Juravinski
Hamilton, Ontario, Canada
Recruitment Rates
Recruitment rate at different study sites
Time frame: 2 years
Non-randomized Eligible Patients
Proportion of Eligible patients who are not randomized and reasons for this
Time frame: 2 years
Adherence/Compliance to Oxygenation Strategy
Rate of adherence to the assigned oxygenation strategy (and crossover rates)
Time frame: 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
Time frame: 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
Time frame: 2 years
Number of participants in each group who need endotracheal intubation
Need for endotracheal intubation after randomization
Time frame: 28 and 60 days
Duration of invasive mechanical ventilation after randomization up to 28 and 60 days
Duration of invasive mechanical ventilation after randomization up to 28 and 60 days
Time frame: 28 and 60 days
Duration of non-invasive respiratory support after randomization up to 28 and 60 days
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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
...and 1 more locations
Duration of non-invasive mechanical ventilation after randomization up to 60 days
Time frame: 60 days
ICU length of stay
days of ICU up to 28 days after randomization
Time frame: 28 days
All cause mortality
All cause mortality to 60 days
Time frame: 60 days
COVID-19 infection after hospitalization
diagnosis of COVID-19
Time frame: 28 days
Health related quality of life
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.
Time frame: 180 days
Mortality at 180 days
Mortality to 180 days
Time frame: 180 days
Activities of Daily Living
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.
Time frame: 180 days
Ventilator-Free Days to day 28, analyzed as an ordinal variable, with death = 0 days
Ventilator-Free Days to day 28, analyzed as an ordinal variable, with death = 0 days
Time frame: 28 days