HFNO 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)
High-flow Nasal Oxygen With or Without Helmet Non-invasive Ventilation for Oxygenation Support in Acute Respiratory Failure (the HONOUR Pilot Trial)
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).
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
- 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
Exclusion Criteria:
- 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.)
Overview
Recruitment Status
Recruiting
ClinicalTrials.gov (NCT#)
NCT05078034
Trial contact
clinicaltrialinquiries@sunnybrook.ca
Conditions
- Helmet Non Invasive Ventilation
- High Flow Nasal Oxygen