Carlo W A, Siner B, Chatburn R L, Robertson S, Martin R J
Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland, Ohio 44106.
J Pediatr. 1990 Nov;117(5):765-70. doi: 10.1016/s0022-3476(05)83341-4.
To determine whether early use of high-frequency jet ventilation reduces neonatal mortality or pulmonary morbidity rates, we randomly selected 42 infants with clinical and radiographic evidence of severe respiratory distress syndrome to receive either high-frequency jet ventilation or conventional ventilation. Separate sequential analyses (two-sided, alpha = 0.05, power = 0.95 to detect 85:15 advantage) were performed for mortality rates, air leaks, bronchopulmonary dysplasia, intraventricular hemorrhage, and assignment crossover, and a combined analysis was performed, with death overriding other outcome variables. Enrollment was completed when the combined analysis reached the sequential design boundary indicating no treatment difference. Mortality rates (19% among infants receiving high-frequency jet ventilation vs 24% among infants receiving conventional ventilation), the incidence of air leaks (48% vs 52%), bronchopulmonary dysplasia (39% vs 41%), and intraventricular hemorrhage (33% vs 43%), and assignment crossovers (14% vs 24%) did not differs significantly between the treatment groups. We conclude that early use of high-frequency jet ventilation does not prevent or substantially reduce mortality or morbidity rates associated with assisted ventilation.
为确定早期使用高频喷射通气是否可降低新生儿死亡率或肺部发病率，我们随机选取了42例有严重呼吸窘迫综合征临床及影像学证据的婴儿，分别给予高频喷射通气或传统通气治疗。对死亡率、气漏、支气管肺发育不良、脑室内出血及分组交叉情况进行了单独的序贯分析（双侧检验，α = 0.05，检验效能=0.95以检测出85:15的优势），并进行了综合分析，死亡情况优先于其他结局变量。当综合分析达到序贯设计边界表明无治疗差异时，入组结束。治疗组间的死亡率（接受高频喷射通气的婴儿为19%，接受传统通气的婴儿为24%）、气漏发生率（48%对52%）、支气管肺发育不良（39%对41%）、脑室内出血（33%对43%）及分组交叉情况（14%对24%）均无显著差异。我们得出结论，早期使用高频喷射通气不能预防或显著降低与辅助通气相关的死亡率或发病率。
