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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Weaning Failure, Acute Respiratory Failure

Intervention / Treatment
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* Device: Optiflow (Fisher & Paykel Healthcare)
* Device: Venturi mask


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Mechanical ventilation > 24 hours Signed Informed Consent Successful spontaneous breathing trial 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: Pregnancy Presence of tracheostomy 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nasal high-flow oxygen therapy<br>High-flow, fully humidified oxygen delivered through nasal cannula (Optiflow, Fisher & Paykel Healthcare) after extubation up to ICU discharge | Device: Optiflow (Fisher & Paykel Healthcare)<br>* This device delivers high-flow oxygen through nasal cannula<br>|
| Active Comparator: Venturi mask oxygen therapy<br>Oxygen delivered through standard Venturi mask after extubation up to ICU discharge | Device: Venturi mask<br>* This device delivers low-flow oxygen at predetermined concentrations<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reintubation |  | within 72 hours after extubation or at ICU discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oxygen therapy, Extubation, Weaning, Reintubation, Acute respiratory failure