The goal of the HIGH-WEAN trial was to evaluate if high-flow nasal oxygen with noninvasive ventilation, compared with high-flow nasal oxygen alone, decreased the rate of reintubation within the first 7 days after extubation in the ICU.
Patients were randomly assigned in a 1:1 ratio to receive high-flow nasal oxygen alone (control group) or along with noninvasive ventilation (intervention group) immediately after extubation.
The median duration of mechanical ventilation prior to extubation was 5 days. At the time of extubation, 111 patients (17%) had hypercapnia (Paco2 >45 mm Hg).
High-flow nasal oxygen alone group
Patients were continuously treated by high-flow nasal oxygen alone for a mean of 42 hours within the first 48 hours with a flow of 50 L/min and fraction of inspired oxygen (0.41 FiO2) adjusted to obtain adequate oxygenation, with an oxygen saturation as measured by pulse oximetry (SpO2) of ≥ 92%.
High-flow + NIV group
Patients assigned to the intervention group (O2 + NIV) were treated with high-flow nasal oxygen alternating with noninvasive ventilation. Noninvasive ventilation was initiated immediately after extubation with a first session of ≥ 4 hours. The minimal duration was of 12 hours. Continuous application of noninvasive ventilation was promoted throughout the entire night period. FiO2 was adjusted to obtain adequate oxygenation (Spo2 ≥92%). Between noninvasive ventilation sessions, high-flow nasal oxygen was delivered.
Study Population of the HIGH-WEAN Trial
- Total number of enrollees: 3121
- Patients included in the analysis: 641
- Patients assigned to control group (only high-flow nasal oxygen): 302
- Patients assigned to intervention group (high-flow nasal oxygen with non-invasive ventilation): 339
- Difficult or prolonged weaning: 32%
- Mean patient age: 70
- Percentage female: 34%
- Patients at high risk of reintubation: ≥65 years or with an underlying cardiac or respiratory disease
- Extubation after at least 24h of mechanical ventilation
- At low risk of extubation failure
- Intubated <24 h
- Underlying chronic neuromuscular disease (myopathy or myasthenia gravis)
- Under law protection or non affiliated to health system
- Do-not-reintubate order at the time of extubation
- Long-term treatment with noninvasive ventilation or continuous positive airway pressure at home
- Unplanned extubation (accidental or self-extubation)
- Contraindication to noninvasive ventilation
- Traumatic brain injury
Principal Findings of the HIGH-WEAN Trial:
Comparisons are high-flow nasal oxygen alone vs. high-flow nasal oxygen with noninvasive ventilation
Reintubation rates at day 7:
18% vs. 12% – Absolute difference −6.4% (95% CI, −12.0 to −0.9; P=.02)
Postextubation respiratory failure at day 7:
29% vs. 21% Absolute difference −8.5% (95% CI, −15.2 to −1.8 ; P=.01)
- At 48 h: 12% vs. 7%
Absolute difference −4.8% (95% CI, −9.6 to −0.3; P= .04)
- At 72 h: 16% vs. 9%
Absolute difference −6.7% (95% CI, −11.9 to −1.7; P= .009)
- Up until ICU discharge: 20% vs 12%
Absolute difference −7.4% (95% CI, −13.2 to −1.8; P=.009)
Length of stay, median (IQR), days:
- In ICU: 11 vs. 12
Absolute difference 0.5% (95% CI, −1.6 to 2.6; P= .55)
- In hospital: 23 vs. 25
Absolute difference 2.3%(95% CI, −1.4 to 6.1; P=.31)
- In ICU: 26% vs. 21
Absolute difference −2.4%(95% CI, −6.7 to 1.7; P=.25)
- In hospital: 46% vs. 54%
Absolute difference 0.7% (95% CI, −5.0 to 6.3; P=.80)
- At day28: 33% vs. 39%
Absolute difference 0.6% (95% CI, −4.4 to 5.5; P=.82)
- At day 90: 65% vs. 62%
Absolute difference −3.2% (95% CI, −9.5 to 2.9; P=0.30)
Patients meeting reintubation criteria:
- During ICU stay: 65% vs. 49%
Absolute difference −7.1% (95% CI, −13.1 to −1.1; P=.02)
- Mortality or reintubation in ICU: 64% vs. 51%
Absolute difference −6.2% (95% CI, −12.2 to −0.2; P= .04)
- Mortality of reintubated patients: 36% vs. 27%
Absolute difference −8.8% (95% CI, −25.7 to 9.9; P= .35)
The reason for reintubation was severe respiratory failure in 88 patients, neurological failure in 37 patients, hemodynamic failure in 16 patients, and respiratory or cardiac arrest in 10 patients.
One hour after treatment initiation, Pao2:FiO2 was higher with noninvasive ventilation than with high-flow nasal oxygen alone. An absolute difference of 8% in the rate of reintubation was seen in favor of NIV + O2. Mortality in the ICU, in the hospital, and at day 90 were not significantly different between groups.
In mechanically ventilated patients at high risk of extubation failure, the use of high-flow nasal oxygen with noninvasive ventilation immediately after extubation significantly decreased the risk of reintubation compared with high-flow nasal oxygen alone.
HIGH-WEAN Trial Via JAMA