Comparison of Pre-oxygenation by Non-invasive Ventilation With High-flow Nasal Oxygen Therapy for Intubation of Intensive Care Patients in Cases of Acute Respiratory Failure: A Prospective, Randomized, Controlled Study (FLORALI 2)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Respiratory Failure
- Sponsor
- Poitiers University Hospital
- Enrollment
- 320
- Locations
- 27
- Primary Endpoint
- Severe desaturation as defined by a pulse oxymetry below 80%
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The aim of the study is to evaluate the incidence of severe hypoxemia episodes during the intubation procedure with two methods of pre-oxygenation:
- NIV (Non Invasive Ventilation)
- HFNC (High-flow nasal canula oxygen therapy)
Detailed Description
Design: Clinical randomized, open, multicenter, comparative trial, with parallel groups aimed at evaluating a medical device. Selection of patients admitted to the ICU for acute respiratory failure, requiring endotracheal intubation. Randomized study, inclusion in two groups: NIV or HFNC. Experimental group: NHFC group, preoxygenation by NHFC: oxygen flow rate of 60 L / min and 100% FiO2. Control group: NIV group, preoxygenation by NIV: pressure support set for an exhaled tidal volume of 6-8 ml / kg of ideal body weight, PEEP of 5 cm H2O and FiO2 at 100%. Duration of participation of each patient: 28 days
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Severe desaturation as defined by a pulse oxymetry below 80%
Time Frame: through five minutes after preoxygenation period
drop below 80% of pulse oxymetry measurement