Phase
Condition
Lung Injury
Acute Respiratory Distress Syndrome (Ards)
Respiratory Failure
Treatment
High Flow Nasal Oxygen
Helmet Non-Invasive Ventilation (HNIV)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 ofscreening 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 10Litres / minute, or any non-invasive oxygenation strategy
Not already intubated or with tracheostomy
Exclusion
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 refractoryhypoxemia 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 ofhypercapnic respiratory failure or acute congestive heart failure
Known neuromuscular disease
Patients being transitioned to Palliative care or unlikely to survive more than 24hours
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 orwho have upper limb/torso fractures that would preclude them from safe applicationof the helmet
Clinician decision that positive pressure to face and/or nasal pharynx is acontraindication (eg. Transphenoidal surgery, basal skull fracture etc.)
Study Design
Study Description
Connect with a study center
University of Calgary
Calgary, Alberta T2N 4N1
CanadaActive - Recruiting
University of Alberta Hospital
Edmonton, Alberta T6G 2B7
CanadaActive - Recruiting
Hamilton Health Sciences- Juravinski
Hamilton, Ontario
CanadaActive - Recruiting
Kingston General Hospital
Kingston, Ontario
CanadaActive - Recruiting
London Health Sciences Centre
London, Ontario
CanadaActive - Recruiting
Ottawa Hospital
Ottawa, Ontario K1H 8L6
CanadaActive - Recruiting
Mount Sinai Hospital
Toronto, Ontario
CanadaActive - Recruiting
North York General Hospital
Toronto, Ontario M2K 1E1
CanadaActive - Recruiting
St. Michael's Hospital
Toronto, Ontario M5B 1W8
CanadaActive - Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario M4N 3M5
CanadaActive - Recruiting
University Health Network Toronto General
Toronto, Ontario
CanadaActive - Recruiting
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