Comparison of Extubation Success between Prophylactic Helmet NIV and Facemask NIV in High Risk Postextubation Patients;A Randomized Controlled Trial

Background: Post-extubation respiratory failure is a common complication in planned extubated patients, which increases mortality, particularly in high-risk patients. Noninvasive ventilation (NIV) with a facemask effectively prevents post-extubation respiratory failure, but helmet NIV use immediately after extubation is still unproven. Objective: To compare the success rates of extubation with prophylactic helmet NIV and facemask NIV in the first 48 hours in patients at high risk of developing post-extubation respiratory failure. Methods: The study was a single-center randomized controlled trial. The data were analyzed for 114 patients at high risk of extubation failure between June 2022 and June 2023. Patients were randomly assigned to either helmet NIV or facemask NIV for 24 hours after extubation. The primary outcome was successful extubation within the first 48 hours. Secondary outcomes included the rate of reintubation within seven days, the rate of NIV intolerance, complications, comfort score, and hemodynamic and gas exchange parameters during the study period. Results: During the study, 114 patients met the inclusion criteria and were randomly assigned to one of the two groups: facemask NIV or helmet NIV. There were no statistically significant differences in baseline characteristics, including underlying diseases, severity scores, and baseline hemodynamic and gas exchange parameters. The extubation success rate was similar in both groups: 85.96% in the helmet group and 87.72% in the facemask NIV (p = 0.782). In helmet NIV, pressure support and PEEP level were higher than in facemask NIV (12.28±2.23 versus 8.58±2.05, p <0.001, 6.14±1.42 versus 5.54±1.18, p = 0.016). Compared with facemask NIV, helmet NIV had lower air leakage from baseline to 24 hours after extubation (p <0.001). The helmet group had a significantly higher rate of NIV intolerance than the control group (75.44% versus 21.05%, p <0.001). There were no intergroup differences in the reintubation rate within seven days and gas exchanges, including pH, PaO2/FiO2, and PaCO2. Compared with the facemask NIV, the adverse events, namely pressure sore and asynchrony, were lower in the helmet group, but the noise was higher (p <0.001). Conclusion: The success rates of extubation in mechanically ventilated patients at high risk of extubation failure did not differ between helmet NIV and facemask NIV.