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Research on Respiratory Support Decision-Making for Mechanically Ventilated ICU Patients Based on a Physiological World Model

2026年9月16日 更新者:Jialin Liu、Ruijin Hospital

Mechanical ventilation is essential for ICU patients with respiratory failure, yet ventilator adjustment and weaning decisions remain experience-dependent and highly variable. Current single-point metrics such as the oxygenation index cannot distinguish true recovery from support-dependent stability-the same oxygenation level may reflect either. This study uses EHR data from 4,232 invasively ventilated ICU patients at Ruijin Hospital (2016-2026) to develop LAVENT, a deep learning-based physiological world model of respiratory dynamics. LAVENT learns the co-evolution of patient physiology and respiratory support, generates 96-hour multivariate trajectories under candidate FiO₂/PEEP settings, and compares alternative ventilation strategies within the same patient state. External validation uses the MIMIC-IV database (n = 29,899). This retrospective observational study uses only existing EHR data, with no prospective intervention or biospecimen collection.

研究概览

地位

尚未招聘

详细说明

Mechanical ventilation is the cornerstone of life support for critically ill patients with respiratory failure in the ICU. However, adjustments to ventilator settings and decisions regarding weaning remain highly dependent on clinical experience, resulting in substantial inter-clinician variability. A fundamental limitation of current practice is that commonly used single-point metrics-such as the oxygenation index-cannot reliably reflect a patient's true recovery state across different levels of respiratory support. The same oxygenation level may indicate genuine recovery in a patient on low support, or persistent respiratory failure masked by high ventilatory support. This conflation of "true recovery" with "support-dependent stability" is a major contributor to weaning failure and delayed extubation.

To address this challenge, this study will leverage electronic health record (EHR) data from ICU patients who received invasive mechanical ventilation at Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, between 2016 and 2026 (RuiICU-P1 cohort, n = 4,232), to develop a deep learning-based physiological world model of respiratory dynamics (LAVENT). The model is designed to: (1) learn the co-evolutionary dynamics between a patient's physiological state and respiratory support; (2) generate 96-hour multivariate clinical trajectories given the current patient state and candidate ventilator settings (FiO₂, PEEP); and (3) compare the differential clinical outcomes of alternative ventilator adjustment strategies within the same patient state. External validation will be performed using the public MIMIC-IV database (n = 29,899) to assess model transferability across healthcare systems.

This is a retrospective, observational study using only existing EHR data, without any prospective patient intervention, additional examinations, or biospecimen collection.

研究类型

观察性的

注册 (估计的)

4232

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。

学习联系方式

学习地点

    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国、200025
        • Ruijin hospital
        • 接触:

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

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Adult ICU patients (≥18 years) who received invasive mechanical ventilation at the Department of Critical Care Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, between January 2016 and June 2026.

描述

Inclusion Criteria:

  • Inclusion criteria:
  • age ≥ 18 years
  • received invasive mechanical ventilation during ICU stay
  • had complete 48hour baseline data and 96hour followup data.

Exclusion Criteria:

  • age < 18 years
  • duration of mechanical ventilation < 24 hours
  • missing rate > 50% for key variables (FiO₂, PEEP, SpO₂, respiratory rate)
  • received ECMO therapy.

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

  • 观测模型:COHORT
  • 时间观点:RETROSPECTIVE

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
success rate of ventilator weaning
大体时间:28 days

The proportion of participants who successfully achieve liberation from invasive mechanical ventilation (weaning success), expressed as a percentage of all participants who undergo a weaning attempt

28 days

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。

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 (估计的)

2026年9月14日

初级完成 (估计的)

2028年12月31日

研究完成 (估计的)

2029年12月31日

研究注册日期

首次提交

2026年9月10日

首先提交符合 QC 标准的

2026年9月16日

首次发布 (实际的)

2026年9月22日

研究记录更新

最后更新发布 (实际的)

2026年9月22日

上次提交的符合 QC 标准的更新

2026年9月16日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • RJ2026681

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Privacy and confidentiality constraints: The source data contain sensitive clinical information derived from electronic medical records. Although all data are de-identified before analysis, the combination of detailed longitudinal physiological variables, ventilator parameters, and clinical outcomes carries a residual risk of re-identification. Institutional privacy policies and the approved ethics protocol do not permit public deposition of individual-level data.

Ethics approval and consent limitations: This study is approved with a waiver of informed consent for retrospective use of existing EHR data. The ethics approval covers secondary analysis for the specified research purpose only, and does not extend to unrestricted sharing or redistribution of individual-level records.

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

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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