HNFO With or Without Helmet NIV for Oxygenation Support in Acute Respiratory Failure Pilot RCT (HONOUR)
Acute Hypoxemic Respiratory Failure
About this trial
This is an interventional treatment trial for Acute Hypoxemic Respiratory Failure focused on measuring High Flow Nasal Oxygen, Helmet Non Invasive Ventilation
Eligibility Criteria
Inclusion Criteria:
- 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
b. 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
Exclusion Criteria:
- Patients who are intubated or with tracheostomy
- Already on HFNO or other non-invasive oxygenation strategy at FiO2>=0.4 for the last 18 hours
- 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 acute exacerbation of chronic 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 (ie. Transphenoidal surgery etc.)
Sites / Locations
- Hamilton Health Sciences- JuravinskiRecruiting
- Kingston General HospitalRecruiting
- London Health Sciences CentreRecruiting
- Sunnybrook Health Sciences CentreRecruiting
- Mount Sinai HospitalRecruiting
- University Health Network Toronto GeneralRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
HFNO
H-NIV
High Flow Nasal Oxygen alone
Helmet Non-Invasive ventilation for a minimum of 12 hours per day with HFNO between sessions