Impact of Nasal High-flow vs Venturi Mask Oxygen Therapy on Weaning Outcome: a Multicenter, Randomized, Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 500
- Locations
- 15
- Primary Endpoint
- Reintubation
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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)
Arms & Interventions
Nasal high-flow oxygen therapy
High-flow, fully humidified oxygen delivered through nasal cannula (Optiflow, Fisher & Paykel Healthcare) after extubation up to ICU discharge
Intervention: Optiflow (Fisher & Paykel Healthcare) (Device)
Venturi mask oxygen therapy
Oxygen delivered through standard Venturi mask after extubation up to ICU discharge
Intervention: Venturi mask (Device)
Outcomes
Primary Outcomes
Reintubation
Time Frame: within 72 hours after extubation or at ICU discharge
Secondary Outcomes
- 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)
- 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)
- Hospital length of stay(at day 28 from the inclusion in the study or at hospital discharge)
Investigators
Salvatore Maurizio MAGGIORE, MD, PhD
Associate Professor
Catholic University of the Sacred Heart