Impact of Nasal High-flow vs Venturi Mask Oxygen Therapy on Weaning Outcome: a Multicenter, Randomized, Controlled Trial

Not Applicable

Completed

• Conditions: Acute Respiratory Failure; Weaning Failure
• Interventions: Device: Optiflow (Fisher & Paykel Healthcare); Device: Venturi mask

• Registration Number: NCT02107183
• Lead Sponsor: Catholic University of the Sacred Heart

Brief Summary

The purpose of this study is to determine whether, as compared with the Venturi mask, a nasal, high-flow oxygenation device (Optiflow) may reduce the extubation failure rate in patients needing oxygen therapy after extubation.

Detailed Description

This study compares the effects of two devices for oxygen therapy, the nasal, high-flow (Optiflow, intervention) and the Venturi mask (control), on the outcome of extubation. Available data suggest that Optiflow can improve oxygenation and patient's comfort in critically ill patients after extubation. The study hypothesis is that Optiflow may reduce the extubation failure rate in these patients.

In the intervention group, patients fulfilling inclusion criteria and not presenting any of the exclusion criteria will receive high-flow oxygen through nasal cannula (Optiflow, Fisher \& Paykel Healthcare Ltd., New Zealand) after extubation. The oxygen concentration (FiO2) will be set to reach an oxygenation target similar to control patients (see below), while the gas flow rate will be set at 50 L/min.

In the control group, patients fulfilling inclusion criteria and not presenting any of the exclusion criteria will receive oxygen through a standard Venturi mask after extubation. The FiO2 will be set to obtain a arterial oxygen saturation (SpO2) between 92% and 98% (or between 88% and 95% in hypercapnic patients). Further FiO2 modifications will be performed by the attending physicians to meet the oxygenation target.

Study Timeline

• Study First Submitted: 2014-04-04
• Study First Submitted QC: 2014-04-04
• Study First Posted: 2014-04-08
• Study Start: 2014-06
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-18
• Last Update Posted: 2017-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1. Age ≥ 18 years
2. Mechanical ventilation > 24 hours
3. Signed Informed Consent
4. Successful spontaneous breathing trial
5. PaO2/FiO2 ratio ≤ 300 (or SpO2/FiO2 ratio ≤ 300 if SpO2 is lower than 98%) within 30 min after extubation while breathing through a Venturi mask with a delivered FiO2 of 31%

Exclusion Criteria

1. Pregnancy
2. Presence of tracheostomy
3. Need for immediate post-extubation Non-Invasive Ventilation (>3 consecutive failures of the spontaneous breathing trial and/or a PaCO2 > 45 mmHg before the spontaneous breathing trial, with a respiratory rate ≥ 25/min)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nasal high-flow oxygen therapy	Optiflow (Fisher & Paykel Healthcare)	High-flow, fully humidified oxygen delivered through nasal cannula (Optiflow, Fisher \& Paykel Healthcare) after extubation up to ICU discharge
Venturi mask oxygen therapy	Venturi mask	Oxygen delivered through standard Venturi mask after extubation up to ICU discharge

Primary Outcome Measures

Name	Time	Method
Reintubation	within 72 hours after extubation or at ICU discharge

Secondary Outcome Measures

Name	Time	Method
ICU readmission	at day 28 from inclusion in the study
ICU mortality	at day 28 from inclusion in the study
Hospital mortality	at day 28 from inclusion in the study
Need for Non-Invasive Ventilation	at day 28 after inclusion in the study or at ICU discharge
ICU length of stay	at day 28 from the inclusion in the study or at ICU discharge
Hospital length of stay	at day 28 from the inclusion in the study or at hospital discharge

Trial Locations

Locations (14)

Sainte-Marguerite University Hospital; 🇫🇷 Marseille, France

Lapeyronie University Hospital; 🇫🇷 Montpellier, France

Saint Eloi University Hospital; 🇫🇷 Montpellier, France

Policlinico University Hospital; 🇮🇹 Bari, Italy

University Hospital; 🇫🇷 Poitiers, France

Catholic University of the Sacred Heart, A. Gemelli Hospital; 🇮🇹 Rome, Italy

Università del Piemonte Orientale, Ospedale della Carità; 🇮🇹 Novara, Italy

Università del Piemonte Orientale, Sant'Andrea Hospital; 🇮🇹 Vercelli, Italy

Sant Pau University Hospital; 🇪🇸 Barcelona, Spain

Evangelismos University Hospital; 🇬🇷 Athens, Greece

Le Molinette University Hospital; 🇮🇹 Turin, Italy

La Pitie-Salpetriere University Hospital; 🇫🇷 Paris, France

Louis Mourier University Hospital; 🇫🇷 Paris, France

Saint-Louis University Hospital; 🇫🇷 Paris, France