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External Validation of AI-Aided Weaning Software Using Multicenter Retrospective Data

2026年6月17日 更新者:Chieh-Liang Wu、Taichung Veterans General Hospital

Using Multicenter Retrospective Data to Validate the Performance of AI-Aided Weaning Software

This multicenter retrospective study aims to externally validate an artificial intelligence-aided weaning software developed using intensive care unit data from Taichung Veterans General Hospital between 2015 and 2019. The model predicts the optimal timing for extubation using routinely collected clinical variables including ventilator parameters, physiologic measurements, and fluid and nutrition information. De-identified data from four hospitals collected between 2020 and 2024 will be used to evaluate model performance. Performance metrics include sensitivity, specificity, accuracy, area under the receiver operating characteristic curve (AUROC), and F1 score.

研究概览

地位

完全的

详细说明

Critical care generates a large amount of digitized clinical data that may benefit from artificial intelligence-assisted decision support. The AI-Aided Weaning Software was previously developed using ICU data from Taichung Veterans General Hospital collected between 2015 and 2019.

This retrospective multicenter validation study will evaluate the external performance of the established model using independent datasets from four hospitals in Taiwan, including Taichung Veterans General Hospital, Mackay Memorial Hospital, Kaohsiung Medical University Chung-Ho Memorial Hospital, and Tungs' Taichung MetroHarbor Hospital.

The study population includes adult ICU patients with respiratory failure who received mechanical ventilation for at least 72 hours between January 2020 and December 2024. De-identified routine clinical records will be collected according to a predefined case report form and analyzed centrally.

The primary objective is to assess the external validity of the AI-Aided Weaning Software across different hospitals. Model performance will be evaluated using sensitivity, specificity, accuracy, AUROC, and F1 score.

研究类型

观察性的

注册 (实际的)

1500

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Taichung、台湾
        • Taichung Veterans General Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Adult patients with acute respiratory failure who were admitted to participating hospitals between January 2022 and December 2024 and required invasive mechanical ventilation for at least 24 hours. This is a retrospective study using existing clinical and imaging data for model validation.

描述

Inclusion Criteria:

  • Adult patients aged 20 years or older.
  • Admitted to the intensive care unit (ICU) at one of the participating hospitals between January 1, 2020 and December 31, 2024.
  • Received invasive mechanical ventilation for at least 72 hours.
  • Availability of de-identified clinical data required for model validation.

Exclusion Criteria:

  • Patients who did not receive invasive mechanical ventilation.
  • Duration of mechanical ventilation less than 72 hours.
  • Missing key clinical variables required for model validation.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
Mechanically Ventilated ICU Patients
Adult intensive care unit patients aged 20 years or older who received invasive mechanical ventilation for at least 72 hours between January 2020 and December 2024 at four participating hospitals. Retrospective de-identified clinical data were used to validate the performance of AI-Aided Weaning Software.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Model Performance (AUROC)
大体时间:Using data collected during ICU admission
Area under the receiver operating characteristic curve (AUROC) for predicting successful extubation. AUROC ranges from 0.5 to 1.0, with higher values indicating better discriminative performance of the prediction model.
Using data collected during ICU admission

次要结果测量

结果测量
措施说明
大体时间
Sensitivity
大体时间:ICU admission
SensitivitySensitivity of the prediction model for successful extubation. Sensitivity ranges from 0 to 1 (or 0% to 100%), with higher values indicating better identification of patients who achieve successful extubation.
ICU admission
Specificity
大体时间:ICU admission
Specificity of the prediction model for successful extubation. Specificity ranges from 0 to 1 (or 0% to 100%), with higher values indicating better identification of patients who do not achieve successful extubation.
ICU admission
Accuracy
大体时间:ICU admission
Accuracy of the prediction model for successful extubation. Accuracy ranges from 0 to 1 (or 0% to 100%), with higher values indicating better overall prediction performance.
ICU admission
F1 Score
大体时间:ICU admission
F1 score of the prediction model for successful extubation. F1 score ranges from 0 to 1, with higher values indicating better balance between precision and recall.
ICU admission

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年1月1日

初级完成 (实际的)

2024年12月31日

研究完成 (实际的)

2024年12月31日

研究注册日期

首次提交

2026年6月14日

首先提交符合 QC 标准的

2026年6月14日

首次发布 (实际的)

2026年6月18日

研究记录更新

最后更新发布 (实际的)

2026年6月22日

上次提交的符合 QC 标准的更新

2026年6月17日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • TCVGH-AI-WEAN-2026
  • TCVGH-AI-Weaning-2026 (其他标识符:Taichung Veterans General Hospital)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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