Respiratory care · 2026
Noninvasive Ventilation vs High-Flow Nasal Cannula in High-Risk Children: A Noninferiority Randomized Clinical Trial.
СтатьяРандомизированное исследованиеEquivalence TrialСравнительное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Sachdev Anil, Panday Mukul, Jain Sapna, Sawhney Nikhita, Gupta Neeraj, Gupta Dhiren, Gupta Suresh, Chugh Parul
Аннотация
BACKGROUND: The role of noninvasive ventilation (NIV) and heated humidified high-flow nasal cannula (HFNC) in children with high risk for extubation failure is not established. The objective of our study was to compare the re-intubation rate within 48 h of extubation in high-risk children while receiving HFNC or NIV.
METHODS: This open-label, parallel, noninferiority randomized trial was conducted on high-risk cases in a 12-bed quaternary-level pediatric ICU. All patients aged 1 month to 18 years receiving invasive mechanical ventilation through an endotracheal tube for >48 h were screened for eligibility. Criteria for high-risk patients for extubation, spontaneous breathing trial, extubation readiness, and re-intubation were defined a priori. Subjects were randomized immediately prior to extubation to receive NIV or HFNC. FIO2, NIV settings, and flow setting for HFNC were selected according to a predefined algorithm. All subjects were monitored for hemodynamic instability and increased work of breathing, and the target SpO2 was 92%.
RESULTS: Intention-to-treat analysis was done with 142 subjects in each group. At baseline, both groups were comparable for severity of disease and organ dysfunction. Re-intubation was required in 15 (10.5%) cases in the NIV and 17 (11.9%) of the HFNC group, with no absolute difference (P = .74). The dosage of dexmedetomidine was significantly lower in the HFNC as compared with the NIV group [(0.85 ± 0.22 versus 1.02 ± 0.13 µg/kg/h; 95% CI 0.12-0.21, P < .001)]. Median (interquartile range) postextubation PICU stay was significantly shorter in HFNC subjects [3 (2-4.75) vs 4 (3-5)] days (P = .02).
CONCLUSIONS: HFNC was noninferior to NIV as respiratory support in high-risk children after extubation.
METHODS: This open-label, parallel, noninferiority randomized trial was conducted on high-risk cases in a 12-bed quaternary-level pediatric ICU. All patients aged 1 month to 18 years receiving invasive mechanical ventilation through an endotracheal tube for >48 h were screened for eligibility. Criteria for high-risk patients for extubation, spontaneous breathing trial, extubation readiness, and re-intubation were defined a priori. Subjects were randomized immediately prior to extubation to receive NIV or HFNC. FIO2, NIV settings, and flow setting for HFNC were selected according to a predefined algorithm. All subjects were monitored for hemodynamic instability and increased work of breathing, and the target SpO2 was 92%.
RESULTS: Intention-to-treat analysis was done with 142 subjects in each group. At baseline, both groups were comparable for severity of disease and organ dysfunction. Re-intubation was required in 15 (10.5%) cases in the NIV and 17 (11.9%) of the HFNC group, with no absolute difference (P = .74). The dosage of dexmedetomidine was significantly lower in the HFNC as compared with the NIV group [(0.85 ± 0.22 versus 1.02 ± 0.13 µg/kg/h; 95% CI 0.12-0.21, P < .001)]. Median (interquartile range) postextubation PICU stay was significantly shorter in HFNC subjects [3 (2-4.75) vs 4 (3-5)] days (P = .02).
CONCLUSIONS: HFNC was noninferior to NIV as respiratory support in high-risk children after extubation.