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

Not Applicable

Completed

• Conditions: Acute Respiratory Failure; Intratracheal Intubation
• Interventions: Procedure: High Flow nasal canula oxygen therapy; Procedure: Noninvasive ventilation

• Registration Number: NCT02668458
• Lead Sponsor: Poitiers University Hospital

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:

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

Study Timeline

• Study First Submitted: 2016-01-19
• Study First Submitted QC: 2016-01-28
• Study First Posted: 2016-01-29
• Study Start: 2016-04
• Primary Completion: 2016-12
• Study Completion: 2017-01
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-10
• Last Update Posted: 2017-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HFNC	High Flow nasal canula oxygen therapy	High-flow nasal canula oxygen therapy. NHFC group, preoxygenation by NHFC: oxygen flow rate of 60 L / min and 100% FiO2
NIV	Noninvasive ventilation	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%.

Primary Outcome Measures

Name	Time	Method
Severe desaturation as defined by a pulse oxymetry below 80%	through five minutes after preoxygenation period	drop below 80% of pulse oxymetry measurement

Trial Locations

Locations (27)

CHU louis MOURIER; 🇫🇷 Colombes, France

CHU La cavale Blanche; 🇫🇷 Brest, France

Chu Mondor; 🇫🇷 Creteil, France

CH St Joseph St Luc; 🇫🇷 Lyon, France

CHU Dijon; 🇫🇷 Dijon, France

CH La Rochelle; 🇫🇷 La Rochelle, France

Limoges University Hospital; 🇫🇷 Limoges, France

CH Vendée; 🇫🇷 La Roche/Yon, France

LYON Sud; 🇫🇷 Lyon, France

Chu Cochin; 🇫🇷 Paris, France

CHU Angers; 🇫🇷 Angers, France

CHU Lille; 🇫🇷 Lille, France

Chu E. Herriot; 🇫🇷 Lyon, France

CHU marseille; 🇫🇷 Marseille, France

CH; 🇫🇷 Montauban, France

CHU Lapeyronie; 🇫🇷 Montpellier, France

Hopital de l'Archet; 🇫🇷 Nice, France

CHU La Source; 🇫🇷 Orleans, France

Chu Tenon; 🇫🇷 Paris, France

CHU La Pitié Salpétrière; 🇫🇷 Paris, France

CHU Guadeloupe; 🇫🇷 POINTE à PITRE, France

CHU Poitiers; 🇫🇷 Poitiers, France

University Hospital of Poitiers; 🇫🇷 Poitiers, France

Hôpital C. NICOLLE; 🇫🇷 Rouen, France

Hôpital FOCH; 🇫🇷 Suresnes, France

CHU Strasbourg; 🇫🇷 Strasbourg, France

Chu Tours; 🇫🇷 Tours, France