Clinical trial NCT05078034: HNFO With or Without Helmet NIV for Oxygenation Support in Acute Respiratory Failure Pilot RCT
Official title: High-flow Nasal Oxygen With or Without Helmet Non-invasive Ventilation for Oxygenation Support in Acute Respiratory Failure (the HONOUR Pilot Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Hypoxemic Respiratory Failure
Keywords: High Flow Nasal Oxygen
Helmet Non Invasive Ventilation
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2021-10-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 randomized control trial
Primary purpose: TREATMENT

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.

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.)

Primary outcomes:
measure: Recruitment Rates
timeFrame: 2 years
measure: Non-randomized Eligible Patients
timeFrame: 2 years
measure: Adherence/Compliance to Oxygenation Strategy
timeFrame: 2 years
measure: Among patients requiring intubation in each group, the number who were intubated according to the pre-specified criteria
timeFrame: 2 years
measure: Time from ICU admission to randomization and initiation of treatment
timeFrame: 2 years
Secondary outcomes:
measure: Number of participants in each group who need endotracheal intubation
timeFrame: 28 and 60 days
measure: Duration of invasive mechanical ventilation after randomization up to 28 and 60 days
timeFrame: 28 and 60 days
measure: Duration of non-invasive respiratory support after randomization up to 28 and 60 days
timeFrame: 60 days
measure: ICU length of stay
timeFrame: 28 days
measure: All cause mortality
timeFrame: 60 days
measure: COVID-19 infection after hospitalization
timeFrame: 28 days
measure: Health related quality of life
timeFrame: 180 days
measure: Mortality at 180 days
timeFrame: 180 days
measure: Activities of Daily Living
timeFrame: 180 days
measure: Ventilator-Free Days to day 28, analyzed as an ordinal variable, with death = 0 days
timeFrame: 28 days
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Hamilton
country: Canada
facility: Hamilton Health Sciences- Juravinski
state: Ontario
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: North York General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Toronto
country: Canada
facility: University Health Network Toronto General
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Damon Scales, MD PhD FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: University Health Network, Toronto
name: Niall Fergusson, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References: