HNFO With or Without Helmet NIV for Oxygenation Support in Acute Respiratory Failure Pilot RCT (NCT05078034) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
HNFO With or Without Helmet NIV for Oxygenation Support in Acute Respiratory Failure Pilot RCT
Canada200 participantsStarted 2022-03-17
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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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:
✓. 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
What they're measuring
1
Recruitment Rates
Timeframe: 2 years
2
Non-randomized Eligible Patients
Timeframe: 2 years
3
Adherence/Compliance to Oxygenation Strategy
Timeframe: 2 years
4
Among patients requiring intubation in each group, the number who were intubated according to the pre-specified criteria
Timeframe: 2 years
5
Time from ICU admission to randomization and initiation of treatment