Respiratory medicine · 2025
Safety and efficacy of a helium-oxygen mix for pediatric respiratory failure associated with anatomical and functional stenotic lesions of the airway: a phase II clinical trial.
СтатьяКлиническое исследование II фазыМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Morikawa Yoshihiko, Morimoto Kenji, Kodani Tadashi, Miyahara Yoko, Nishimura Nao, Saito Osamu, Morikawa Emi, Tomotsune Masako, Kaneko Tetsuji, Makimoto Atsushi, Miura Masaru, Honda Masataka, Shimizu Naoki
Аннотация
OBJECTIVE: To evaluate the safety and efficacy of helium-oxygen mixture in Japanese pediatric patients with respiratory failure due to obstructive airway disease.
STUDY DESIGN: This multicenter, single-arm, open-label trial was conducted at two tertiary pediatric hospitals in Japan. Patients aged <20 years requiring mechanical ventilation for bronchiolitis, congenital tracheal stenosis or asthma exacerbation were received helium-oxygen mixture via mechanical ventilation. The primary endpoint was the incidence of serious adverse events. The secondary endpoints included changes in airway resistance, partial pressure of arterial carbon dioxide (PaCO2), and tidal volume.
RESULTS: Fifteen patients (46.7 % female; median age, 7 months) were enrolled with diagnosis of bronchiolitis (73.3 %), asthma (20.0 %), and congenital tracheal stenosis (6.7 %). No serious adverse events related to helium-oxygen mixture were observed (0 %; 95 % confidence interval [CI]: 0.0-21.8 %). Airway resistance decreased significantly from a baseline mean of 138.1 cm H2O/L/s to 90.7 cm H2O/L/s at 30 min after administration (mean change: -47.4; 95 % CI: -64.2 to -30.6) for an efficacy rate of 93.3 %. The changes in the PaCO2 and tidal volume were not statistically significant. The median time from helium-oxygen mixture administration to extubation was 25.6 h.
CONCLUSIONS: Helium-oxygen mixture appeared to be safe, well tolerated, and was associated with a reduction in airway resistance in pediatric patients with obstructive airway disease.
CLINICAL TRIAL REGISTRATION: jRCT2091220357https://jrct.mhlw.go.jp/latest-detail/jRCT2091220357.
STUDY DESIGN: This multicenter, single-arm, open-label trial was conducted at two tertiary pediatric hospitals in Japan. Patients aged <20 years requiring mechanical ventilation for bronchiolitis, congenital tracheal stenosis or asthma exacerbation were received helium-oxygen mixture via mechanical ventilation. The primary endpoint was the incidence of serious adverse events. The secondary endpoints included changes in airway resistance, partial pressure of arterial carbon dioxide (PaCO2), and tidal volume.
RESULTS: Fifteen patients (46.7 % female; median age, 7 months) were enrolled with diagnosis of bronchiolitis (73.3 %), asthma (20.0 %), and congenital tracheal stenosis (6.7 %). No serious adverse events related to helium-oxygen mixture were observed (0 %; 95 % confidence interval [CI]: 0.0-21.8 %). Airway resistance decreased significantly from a baseline mean of 138.1 cm H2O/L/s to 90.7 cm H2O/L/s at 30 min after administration (mean change: -47.4; 95 % CI: -64.2 to -30.6) for an efficacy rate of 93.3 %. The changes in the PaCO2 and tidal volume were not statistically significant. The median time from helium-oxygen mixture administration to extubation was 25.6 h.
CONCLUSIONS: Helium-oxygen mixture appeared to be safe, well tolerated, and was associated with a reduction in airway resistance in pediatric patients with obstructive airway disease.
CLINICAL TRIAL REGISTRATION: jRCT2091220357https://jrct.mhlw.go.jp/latest-detail/jRCT2091220357.