NCT02668458

Comparison of Pre-oxygenation of NIV and HFNC Therapy for Intubation of ICU Patients With Acute Respiratory Failure

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 320 (actual)
• Sponsor: Poitiers University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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: 1. NIV (Non Invasive Ventilation) 2. 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

Conditions

• Acute Respiratory Failure
• Intratracheal Intubation

Interventions

Type	Name	Description
PROCEDURE	High Flow nasal canula oxygen therapy	Pre-oxygenation with high-flow nasal canula oxygen therapy
PROCEDURE	Noninvasive ventilation	Pre-oxygenation with non-invasive ventilation

Timeline

• Start date: 2016-04-01
• Primary completion: 2016-12-01
• Completion: 2017-01-01
• First posted: 2016-01-29
• Last updated: 2017-10-11

Locations

27 sites across 1 country: France