小儿患者的计算机驱动通气解放方案:一项单中心前瞻性随机对照试验。

A computer-driven ventilator liberation protocol in pediatric patients: a single-center pilot randomized controlled trial.

作者信息

Chen Song, Xiao Changxue, Lu Xue, Liao Min, Liu Chengjun, Xu Feng, Li Jing

机构信息

Department of Critical Care Medicine, Children's Hospital of Chongqing Medical University, National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, Chongqing Key Laboratory of Pediatric Metabolism and Inflammatory Diseases, Chongqing, China.

出版信息

Front Pediatr. 2025 Jul 18;13:1594160. doi: 10.3389/fped.2025.1594160. eCollection 2025.

Abstract

OBJECTIVE

Timely liberation from invasive mechanical ventilation (IMV) is important. We aimed to determine the feasibility of our study protocol for the conduction of a larger prospective trial to examine the utility of a computer-driven liberation protocol in pediatric patients.

DESIGN

Single-center pilot randomized controlled trial.

SETTING

Single, tertiary care, 52-bed, academic pediatric intensive care unit (PICU).

PATIENTS

Patients aged from 28 days to 18 years undergoing IMV for more than 24 h.

INTERVENTIONS

Patients were randomly assigned to test and control groups in a ratio of 1:1. The test group underwent ventilator liberation driven by a computerized algorithm combining protocolized screening, air leak testing, and spontaneous breathing testing. The control group underwent ventilator liberation driven by the attending physician according to standard care.

MEASUREMENTS AND MAIN RESULTS

A total of 40 patients (20 in each group) were randomized. Baseline characteristics of the two groups were similar. Durations of IMV were 95.3 h (95%CI, 9.07-181.53) in the test group and 113.3 h (95%CI, 85.90-140.70) in the control group and were similar ( = 0.62). PICU length of stay [6.9 days [95%CI, 5.00-8.86] vs. 7.0 days [95%CI, 5.58-8.40];  = 0.74] and hospital length of stay [22.9 days [95%CI, 11.48-34.24] vs. 26.9 days [95%CI, 17.86-35.94];  = 0.31] were similar between the test and control groups, respectively.

CONCLUSIONS

Our pilot study suggests that the conduction of a larger prospective trial of a computer-driven ventilator liberation protocol is feasible in our PICU. And a larger trial is needed to further explore the utility of a computer-driven ventilator liberation protocol.

CLINICAL TRIAL REGISTRATION

https://www.chictr.org.cn/showproj.html?proj=168024, Chinese Clinical Trial Registry ChiCTR2200060033.

摘要

目的

及时脱离有创机械通气(IMV)很重要。我们旨在确定我们的研究方案对于开展一项更大规模前瞻性试验的可行性,该试验旨在检验计算机驱动的撤机方案在儿科患者中的效用。

设计

单中心试点随机对照试验。

设置

一家拥有52张床位的三级医疗学术性儿科重症监护病房(PICU)。

患者

年龄在28天至18岁之间、接受IMV超过24小时的患者。

干预措施

患者按1:1的比例随机分配至试验组和对照组。试验组采用由计算机算法驱动的呼吸机撤机,该算法结合了规范化筛查、漏气测试和自主呼吸测试。对照组由主治医生根据标准护理进行呼吸机撤机。

测量指标及主要结果

共40例患者(每组20例)被随机分组。两组的基线特征相似。试验组的IMV持续时间为95.3小时(95%CI,9.07 - 181.53),对照组为113.3小时(95%CI,85.90 - 140.70),两者相似(P = 0.62)。试验组和对照组的PICU住院时间[6.9天[95%CI,5.00 - 8.86] vs. 7.0天[95%CI,5.58 - 8.40];P = 0.74]和住院总时间[22.9天[95%CI,11.48 - 34.24] vs. 26.9天[95%CI,17.86 - 35.94];P = 0.31]分别相似。

结论

我们的试点研究表明,在我们的PICU开展一项更大规模的计算机驱动呼吸机撤机方案前瞻性试验是可行的。需要开展更大规模的试验来进一步探索计算机驱动呼吸机撤机方案的效用。

临床试验注册

https://www.chictr.org.cn/showproj.html?proj=168024,中国临床试验注册中心ChiCTR2200060033

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/29f1/12313617/96fe736588ab/fped-13-1594160-g001.jpg

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