HNFO With or Without Helmet NIV for Oxygenation Support in Acute Respiratory Failure Pilot RCT

Last updated: May 16, 2024
Sponsor: Sunnybrook Health Sciences Centre
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lung Injury

Acute Respiratory Distress Syndrome (Ards)

Respiratory Failure

Treatment

High Flow Nasal Oxygen

Helmet Non-Invasive Ventilation (HNIV)

Clinical Study ID

NCT05078034
HONOUR (3693)
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

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 ofscreening for eligibility (symptom onset during last 14 days) with the following:

  4. Respiratory rate >21bpm or clinical evidence of increased work of breathing and

  5. 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 10Litres / minute, or any non-invasive oxygenation strategy

  6. Not already intubated or with tracheostomy

Exclusion

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 refractoryhypoxemia 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 ofhypercapnic respiratory failure or acute congestive heart failure

  5. Known neuromuscular disease

  6. Patients being transitioned to Palliative care or unlikely to survive more than 24hours

  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 orwho have upper limb/torso fractures that would preclude them from safe applicationof the helmet

  10. Clinician decision that positive pressure to face and/or nasal pharynx is acontraindication (eg. Transphenoidal surgery, basal skull fracture etc.)

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: High Flow Nasal Oxygen
Phase:
Study Start date:
March 17, 2022
Estimated Completion Date:
February 01, 2025

Study 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.

Connect with a study center

  • University of Calgary

    Calgary, Alberta T2N 4N1
    Canada

    Active - Recruiting

  • University of Alberta Hospital

    Edmonton, Alberta T6G 2B7
    Canada

    Active - Recruiting

  • Hamilton Health Sciences- Juravinski

    Hamilton, Ontario
    Canada

    Active - Recruiting

  • Kingston General Hospital

    Kingston, Ontario
    Canada

    Active - Recruiting

  • London Health Sciences Centre

    London, Ontario
    Canada

    Active - Recruiting

  • Ottawa Hospital

    Ottawa, Ontario K1H 8L6
    Canada

    Active - Recruiting

  • Mount Sinai Hospital

    Toronto, Ontario
    Canada

    Active - Recruiting

  • North York General Hospital

    Toronto, Ontario M2K 1E1
    Canada

    Active - Recruiting

  • St. Michael's Hospital

    Toronto, Ontario M5B 1W8
    Canada

    Active - Recruiting

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario M4N 3M5
    Canada

    Active - Recruiting

  • University Health Network Toronto General

    Toronto, Ontario
    Canada

    Active - Recruiting

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