Copenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region of Denmark, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Department of Anesthesiology Critical Care Medicine, Childrens Hospital Los Angeles, Los Angeles, California, USA.
Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD012067. doi: 10.1002/14651858.CD012067.pub3.
Asthma is one of the most common reasons for hospital admission among children, with significant economic burden and impact on quality of life. Non-invasive positive pressure ventilation (NPPV) is increasingly used in the care of children with acute asthma, although the evidence supporting it is weak, and clinical guidelines do not offer any recommendations on its routine use. However, NPPV might be an effective way to improve outcomes for some children with asthma. A previous review did not demonstrate a clear benefit, but was limited by few studies with small sample sizes. This is an update of the previous review.
To assess the benefits and harms of NPPV as an add-on therapy to usual care (e.g. bronchodilators and corticosteroids) in children (< 18 years) with acute asthma.
We searched the Cochrane Airways Group Specialised Register, CENTRAL, MEDLINE, and Embase. We also conducted a search of ClinicalTrials.gov and the WHO ICTRP. We searched all databases from their inception to March 2023, with no restrictions on language of publication.
We included randomised clinical trials (RCTs) assessing NPPV as add-on therapy to usual care versus usual care for children hospitalised for acute asthma exacerbations.
We used standard Cochrane methods.
We included three RCTs randomising 60 children with acute asthma to NPPV and 60 children to control. All included trials assessed the effects of bilevel positive airway pressure (BiPAP) for acute asthma in a paediatric intensive care unit (PICU) setting. None of the trials used continuous positive airway pressure (CPAP). The controls received standard care. The median age of children ranged from three to six years, and asthma severity ranged from moderate to severe. Our primary outcome measures were all-cause mortality, serious adverse events, and asthma symptom score. Secondary outcomes were non-serious adverse events, health-related quality of life, arterial blood gases and pH, pneumonia, cost, and PICU length of stay. None of the trials reported any deaths or serious adverse events (except one trial that reported intubation rate). Two trials reported asthma symptom score, each demonstrating reductions in asthma symptoms in the BiPAP group. In one trial, the asthma symptom score was (mean difference (MD) -2.50, 95% confidence interval (CI) -4.70 to -0.30, P = 0.03; 19 children) lower in the BiPAP group. In the other trial, a cross-over trial, BiPAP was associated with a lower mean asthma symptom score (MD -3.7; 16 children; very low certainty evidence) before cross-over, but investigators did not report a standard deviation, and it could not be estimated from the first phase of the trial before cross-over. The reduction in both trials was above our predefined minimal important difference. Overall, NPPV with standard care may reduce asthma symptom score compared to standard care alone, but the evidence is very uncertain. The only reported serious adverse event was intubation rate in one trial. The trial had an intubation rate of 40% and showed that BiPAP may result in a large reduction in intubation rate (risk ratio 0.47, 95% CI 0.23 to 0.95; 78 children), but the evidence is very uncertain. Post hoc analysis showed that BiPAP may result in a slight decrease in length of PICU stay (MD -0.87 day, 95% CI -1.52 to -0.22; 100 children), but the evidence is very uncertain. Meta-analysis or Trial Sequential Analysis was not possible because of insufficient reporting and different scoring systems. All three trials had high risk of bias with serious imprecision of results, leading to very low certainty of evidence.
AUTHORS' CONCLUSIONS: The currently available evidence for NNPV is uncertain. NPPV may lead to an improvement in asthma symptom score, decreased intubation rate, and slightly shorter PICU stay; however, the evidence is of very low certainty. Larger RCTs with low risk of bias are warranted.
哮喘是导致儿童住院的最常见原因之一,给经济带来了巨大负担,并影响了生活质量。无创正压通气(NPPV)越来越多地用于急性哮喘患儿的治疗,尽管支持它的证据很薄弱,临床指南也没有关于常规使用它的建议。然而,NPPV 可能是改善某些哮喘患儿预后的有效方法。先前的综述没有显示出明确的益处,但受到研究数量少、样本量小的限制。这是对先前综述的更新。
评估 NPPV 作为急性哮喘儿童(<18 岁)附加治疗与常规治疗(如支气管扩张剂和皮质类固醇)相比的益处和危害。
我们检索了 Cochrane 气道组专业注册库、CENTRAL、MEDLINE 和 Embase。我们还对 ClinicalTrials.gov 和世界卫生组织国际临床试验注册平台(WHO ICTRP)进行了检索。我们从所有数据库的创建开始搜索,一直到 2023 年 3 月,对语言没有任何出版限制。
我们纳入了评估 NPPV 作为急性哮喘加重住院患儿附加治疗与常规治疗相比的随机临床试验(RCTs)。
我们使用了标准的 Cochrane 方法。
我们纳入了三项 RCTs,将 60 名急性哮喘患儿随机分为 NPPV 组和对照组。所有纳入的试验均评估了在儿科重症监护病房(PICU)环境中使用双水平正压通气(BiPAP)治疗急性哮喘的效果。没有一项试验使用持续气道正压通气(CPAP)。对照组接受标准治疗。儿童的中位年龄范围从三岁到六岁,哮喘严重程度从中度到重度不等。我们的主要结局指标是全因死亡率、严重不良事件和哮喘症状评分。次要结局指标是不良事件、健康相关生活质量、动脉血气和 pH 值、肺炎、成本和 PICU 住院时间。没有一项试验报告任何死亡或严重不良事件(除了一项试验报告了插管率)。两项试验报告了哮喘症状评分,均显示 BiPAP 组的哮喘症状有所改善。在一项试验中,BiPAP 组的哮喘症状评分(平均差值(MD)-2.50,95%置信区间(CI)-4.70 至-0.30,P = 0.03;19 名儿童)更低。在另一项试验中,一项交叉试验,BiPAP 与交叉前较低的平均哮喘症状评分(MD-3.7;16 名儿童;极低确定性证据)相关,但研究者没有报告标准差,并且无法从交叉前的第一阶段试验中估计。这两项试验的降低都超过了我们预先定义的最小重要差异。总体而言,与单独接受标准治疗相比,NPPV 联合标准治疗可能会降低哮喘症状评分,但证据非常不确定。唯一报告的严重不良事件是一项试验中的插管率。该试验的插管率为 40%,表明 BiPAP 可能会显著降低插管率(风险比 0.47,95%置信区间 0.23 至 0.95;78 名儿童),但证据非常不确定。事后分析显示,BiPAP 可能会使 PICU 住院时间略有缩短(MD-0.87 天,95%置信区间-1.52 至-0.22;100 名儿童),但证据非常不确定。由于报告不充分和不同的评分系统,无法进行荟萃分析或试验序贯分析。所有三项试验都存在很高的偏倚风险,结果严重不精确,导致证据确定性极低。
目前关于 NNPV 的证据尚不确定。NPPV 可能会改善哮喘症状评分、降低插管率,并略微缩短 PICU 住院时间;然而,证据的确定性很低。需要进行低偏倚风险的大型 RCT。