Weaning Failure, Acute Respiratory Failure
Conditions
Keywords
Oxygen therapy, Extubation, Weaning, Reintubation, Acute respiratory failure
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.
Interventions
DEVICEOptiflow (Fisher & Paykel Healthcare)
This device delivers high-flow oxygen through nasal cannula
DEVICEVenturi mask
This device delivers low-flow oxygen at predetermined concentrations
Sponsors
Fisher and Paykel Healthcare
Catholic University of the Sacred Heart
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reintubation | within 72 hours after extubation or at ICU discharge |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Need for Non-Invasive Ventilation | at day 28 after inclusion in the study or at ICU discharge |
| ICU mortality | at day 28 from inclusion in the study |
| Hospital mortality | at day 28 from inclusion in the study |
| ICU readmission | at day 28 from inclusion in the study |
Countries
France, Greece, Italy, Spain
Outcome results
None listed