高流量鼻导管（HFNC）治疗与无创通气（NIV）在毛细支气管炎致急性呼吸衰竭患儿中的比较：一项随机对照试验
"Comparison between high-flow nasal cannula (HFNC) therapy and noninvasive ventilation (NIV) in children with acute respiratory failure by bronchiolitis: a randomized controlled trial".
机构信息
Pediatric Intensive Care Unit, Hospital Municipal Infantil Menino Jesus, São Paulo, São Paulo, Brazil.
Microbiology Department, Universidade de São Paulo, São Paulo, São Paulo, Brazil.
出版信息
BMC Pediatr. 2024 Sep 19;24(1):595. doi: 10.1186/s12887-024-05058-6.
BACKGROUND
The objective of this study was to compare HFNC therapy to noninvasive ventilation (NIV/BiPAP) in children with bronchiolitis who developed respiratory failure. We hypothesized that HFNC therapy would not be inferior to NIV.
METHODS
This was a noninferiority open-label randomized single-center clinical trial conducted at a tertiary Brazilian hospital. Children under 2 years of age with no chronic conditions admitted for bronchiolitis that progressed to mild to moderate respiratory distress (Wood-Downes-Férres score < 8) were randomized to either the HFNC group or NIV (BiPAP) group through sealed envelopes. Vital signs, FiO, Wood-Downes-Férres score and HFNC/NIV parameters were recorded up to 96 h after therapy initiation. Children who developed respiratory failure despite receiving initial therapy were intubated. Crossover was not allowed. The primary outcome analyzed was invasive mechanical ventilation requirement. The secondary outcomes were sedation usage, invasive mechanical ventilation duration, the PICU LOS, the hospital LOS, and mortality rate.
RESULTS
A total of 126 patients were allocated to the NIV group (132 randomized and 6 excluded), and 126 were allocated to the HFNC group (136 randomized and 10 excluded). The median age was 2.5 (1-6) months in the NIV group and 3 (2-7) months in the HFNC group (p = 0,07). RSV was the most common virus isolated in both groups (72% vs. 71.4%, NIV and HFNC, respectively). Thirty-seven patients were intubated in the NIV group and 29 were intubated in the HFNC group (29% vs. 23%, p = 0.25). According to the Farrington-Manning test, with a noninferiority margin of 15%, the difference was 6.3% in favor of HFNC therapy (95% confidence interval: -4.5 to 17.1%, p < 0.0001). There was no significant difference in the PICU LOS or sedation duration. Sedation requirement, hospital LOS and invasive mechanical ventilation duration were lower in the HFNC group.
CONCLUSION
HFNC therapy is noninferior to NIV in infants admitted with mild to moderate respiratory distress caused by bronchiolitis that progresses to respiratory failure.
TRIAL REGISTRATION NUMBERS
U1111-1262-1740; RBR-104z966s. Registered 03/01/2023 (retrospectively registered). ReBEC: https://ensaiosclinicos.gov.br/rg/RBR-104z966s .
背景
本研究旨在比较 HFNC 治疗与无创通气（NIV/BiPAP）在发生呼吸衰竭的毛细支气管炎患儿中的疗效。我们假设 HFNC 治疗不会逊于 NIV。
方法
这是一项在巴西一家三级医院进行的非劣效性、开放标签、单中心临床试验。年龄在 2 岁以下、无慢性疾病、因毛细支气管炎进展为轻度至中度呼吸窘迫（Wood-Downes-Férres 评分<8）而入院的患儿通过密封信封随机分为 HFNC 组或 NIV（BiPAP）组。记录治疗开始后 96 小时内的生命体征、FiO2、Wood-Downes-Férres 评分和 HFNC/NIV 参数。尽管接受了初始治疗，但仍出现呼吸衰竭的患儿进行插管。不允许交叉。主要结局分析是需要有创机械通气。次要结局是镇静剂使用、有创机械通气持续时间、PICU 住院时间、医院住院时间和死亡率。
结果
共有 126 名患儿被分配到 NIV 组（132 名随机分配，6 名排除），126 名患儿被分配到 HFNC 组（136 名随机分配，10 名排除）。NIV 组的中位年龄为 2.5（1-6）个月，HFNC 组为 3（2-7）个月（p=0.07）。两组最常见的病毒分离株均为 RSV（分别为 72%和 71.4%，NIV 和 HFNC）。NIV 组有 37 名患儿插管，HFNC 组有 29 名患儿插管（29%与 23%，p=0.25）。根据 Farrington-Manning 检验，非劣效性边界为 15%，HFNC 治疗的差异有利于 HFNC 治疗 6.3%（95%置信区间：-4.5 至 17.1%，p<0.0001）。两组的 PICU 住院时间或镇静持续时间无显著差异。HFNC 组的镇静需求、医院住院时间和有创机械通气持续时间较低。
结论
HFNC 治疗在因毛细支气管炎导致轻度至中度呼吸窘迫进展为呼吸衰竭而入院的婴儿中与 NIV 相比非劣效。
试验注册号
U1111-1262-1740；RBR-104z966s。于 2023 年 3 月 1 日（回顾性注册）注册。ReBEC：https://ensaiosclinicos.gov.br/rg/RBR-104z966s。
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