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支气管肺炎住院婴儿间歇性与连续性脉搏血氧测定法的随机临床试验。

Intermittent vs Continuous Pulse Oximetry in Hospitalized Infants With Stabilized Bronchiolitis: A Randomized Clinical Trial.

机构信息

Department of Pediatrics, University of Toronto, Toronto, Ontario, Canada.

Institute for Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.

出版信息

JAMA Pediatr. 2021 May 1;175(5):466-474. doi: 10.1001/jamapediatrics.2020.6141.

Abstract

IMPORTANCE

There is low level of evidence and substantial practice variation regarding the use of intermittent or continuous monitoring in infants hospitalized with bronchiolitis.

OBJECTIVE

To compare the effect of intermittent vs continuous pulse oximetry on clinical outcomes.

DESIGN, SETTING, AND PARTICIPANTS: This multicenter, pragmatic randomized clinical trial included infants 4 weeks to 24 months of age who were hospitalized with bronchiolitis from November 1, 2016, to May 31, 2019, with or without supplemental oxygen after stabilization at community and children's hospitals in Ontario, Canada.

INTERVENTIONS

Intermittent (every 4 hours, n = 114) or continuous (n = 115) pulse oximetry, using an oxygen saturation target of 90% or higher.

MAIN OUTCOMES AND MEASURES

The primary outcome was length of hospital stay from randomization to discharge. Secondary outcomes included length of stay from inpatient unit admission to discharge and outcomes measured from randomization: medical interventions, safety (intensive care unit transfer and revisits), parent anxiety and workdays missed, and nursing satisfaction.

RESULTS

Among 229 infants enrolled (median [IQR] age, 4.0 [2.2-8.5] months; 136 [59.4%] male; 101 [44.1%] from community hospital sites), the median length of hospital stay from randomization to discharge was 27.6 hours (interquartile range [IQR], 18.8-49.6 hours) in the intermittent group and 25.4 hours (IQR, 18.3-47.6 hours) in the continuous group (difference of medians, 2.2 hours; 95% CI, -1.9 to 6.3 hours; P = .17). No significant differences were observed between the intermittent and continuous groups in the median length of stay from inpatient unit admission to discharge: 49.1 (IQR, 37.2-87.0) hours vs 46.0 (IQR, 32.5-73.8) hours (P = .13) or in frequencies or durations of hospital interventions, such as oxygen supplementation initiation: 4 of 114 (3.5%) vs. 9 of 115 (7.8%) (P = .16) and median duration of oxygen supplementation: 20.6 (IQR, 7.6-46.1) hours vs. 21.4 (11.6-52.9) hours (P = .66). Similarly, there were no significant differences in frequencies of intensive care unit transfer: 1 of 114 (0.9%) vs 2 of 115 (2.7%) (P = .76); readmission to hospital: 3 of 114 (2.6%) in the intermittent group vs 4 of 115 (3.5%) in the continuous group (P > .99); parent anxiety: mean (SD) parent anxiety score, 2.9 (0.9) in the intermittent group vs 2.8 (0.9) in the continuous group (P = .40); or parent workdays missed: median workdays missed, 1.5 (IQR, 0.5-3.0) vs 1.5 (IQR, 0.5-2.5) (P = .36). Mean (SD) nursing satisfaction with monitoring was significantly greater in the intermittent group: 8.6 (1.7) vs 7.1 (2.8) of 10 workdays; the mean difference was 1.5 (95% CI, 0.9-2.2; P < .001).

CONCLUSIONS AND RELEVANCE

In this randomized clinical trial, among infants hospitalized with stabilized bronchiolitis with and without hypoxia and managed using an oxygen saturation target of 90% or higher, clinical outcomes, including length of hospital stay and safety, were similar with intermittent vs continuous pulse oximetry. Nursing satisfaction was greater with intermittent monitoring. Given that other important clinical practice considerations favor less intense monitoring, these findings support the standard use of intermittent pulse oximetry in stable infants hospitalized with bronchiolitis.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT02947204.

摘要

重要性

在患有毛细支气管炎的住院婴儿中,间歇性或连续监测的使用证据水平低,且存在大量实践差异。

目的

比较间歇性与连续脉搏血氧饱和度监测对临床结局的影响。

设计、设置和参与者:这是一项多中心、实用的随机临床试验,纳入了 2016 年 11 月 1 日至 2019 年 5 月 31 日期间在加拿大安大略省社区和儿童医院稳定后伴有或不伴有低氧血症的住院毛细支气管炎婴儿(4 周至 24 个月龄)。

干预措施

间歇性(每 4 小时一次,n = 114)或连续(n = 115)脉搏血氧饱和度监测,使用 90%或更高的氧饱和度目标。

主要结局和测量指标

主要结局是从随机分组到出院的住院时间。次要结局包括从住院单元入院到出院的住院时间和从随机分组开始测量的结局:医疗干预、安全性(转入重症监护病房和再入院)、父母焦虑和错过工作日、护理满意度。

结果

共纳入 229 名婴儿(中位[IQR]年龄,4.0[2.2-8.5]个月;136[59.4%]为男性;101[44.1%]来自社区医院),随机分组到出院的中位住院时间为 27.6 小时(IQR,18.8-49.6 小时),连续组为 25.4 小时(IQR,18.3-47.6 小时)(中位数差异,2.2 小时;95%CI,-1.9 至 6.3 小时;P = .17)。在从住院单元入院到出院的中位住院时间(49.1[IQR,37.2-87.0]小时 vs 46.0[IQR,32.5-73.8]小时;P = .13)或在频率或持续时间的医院干预,如氧疗开始:4 例(3.5%) vs 9 例(7.8%)(P = .16)和中位氧疗持续时间:20.6(IQR,7.6-46.1)小时 vs 21.4(11.6-52.9)小时(P = .66),两组之间无显著差异。同样,两组之间重症监护病房转移的频率也无显著差异:1 例(0.9%) vs 2 例(2.7%)(P = .76);再次住院:间歇组 3 例(2.6%),连续组 4 例(3.5%)(P > .99);父母焦虑:间歇组父母焦虑评分的平均(SD)为 2.9(0.9),连续组为 2.8(0.9)(P = .40);或父母错过工作日:中位数错过工作日,1.5(IQR,0.5-3.0)vs 1.5(IQR,0.5-2.5)(P = .36)。监测护理满意度的平均(SD)在间歇组显著更高:10 个工作日中,8.6(1.7)vs 7.1(2.8);平均差异为 1.5(95%CI,0.9-2.2;P < .001)。

结论和相关性

在这项随机临床试验中,在伴有或不伴有低氧血症并使用 90%或更高的氧饱和度目标管理的住院毛细支气管炎婴儿中,包括住院时间和安全性在内的临床结局,间歇性与连续脉搏血氧饱和度监测相似。间歇监测的护理满意度更高。鉴于其他重要的临床实践考虑因素有利于减少监测强度,这些发现支持在患有毛细支气管炎的稳定住院婴儿中常规使用间歇性脉搏血氧饱和度监测。

试验注册

ClinicalTrials.gov 标识符:NCT02947204。

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