此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Early Prediction of ICU Hypotension Using Machine Learning (ICU-HypoAI)

2026年7月7日 更新者:Serkan TELLİ、Kutahya Health Sciences University

A Prospective Observational Machine Learning Study for the Early Prediction of Hypotension in Adult Intensive Care Unit Patients

This prospective observational study aims to develop and internally validate a machine learning model for the early prediction of hypotension in adult intensive care unit patients. The model will use routinely collected non-invasive vital signs, heart rate, medication-dose records, and fluid-balance data recorded during standard ICU care. No intervention will be assigned by the study, and patient management will not be changed according to the model output. The primary aim is to predict hypotension 30 minutes before its occurrence; shorter 5- and 15-minute prediction horizons will also be evaluated.

研究概览

地位

完全的

条件

详细说明

Hypotension is a frequent hemodynamic event in critically ill patients and may occur before clear clinical deterioration is recognized. Earlier identification of patients at risk may support closer clinical attention and more timely evaluation. This study is designed as a prospective, observational machine learning study in adult intensive care unit patients.

Routinely available ICU data will be collected at five-minute intervals, including systolic, mean, and diastolic non-invasive blood pressure, heart rate, medication-dose entries, and fluid-balance records. These data will be used to construct time-dependent features reflecting recent values, short-term changes, and rolling trends. Hypotension will be defined at each five-minute time point as systolic blood pressure below 90 mmHg, mean arterial pressure below 65 mmHg, or diastolic blood pressure below 60 mmHg.

The primary prediction horizon will be 30 minutes. Separate secondary analyses will evaluate 5- and 15-minute prediction horizons. A gradient-boosted decision-tree model will be developed and internally validated using patient-level data partitioning to avoid assigning observations from the same patient to both training and validation sets. Model performance will be assessed using discrimination, classification performance, and calibration measures. Feature-importance analyses will be used to describe the variables contributing to model predictions.

The study is observational. No treatment, medication, device, alarm, or clinical decision will be assigned by the study protocol. The prediction model will be developed and evaluated using collected data and will not be used to guide real-time patient management during the study period.

研究类型

观察性的

注册 (实际的)

107

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

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

The study population will consist of consecutive adult patients monitored in the adult intensive care unit of Kutahya Health Sciences University during the study period. Routine clinical monitoring data, including non-invasive blood pressure, heart rate, medication-dose records, and fluid-balance data, will be used for machine learning model development and internal validation. No treatment or intervention will be assigned by the study protocol.

描述

Inclusion Criteria:

  • Age 18 years or older
  • Admission to the adult intensive care unit during the study period
  • Length of stay in the intensive care unit of at least 24 hours
  • Availability of routine intensive care unit monitoring data
  • Availability of non-invasive blood pressure and heart rate measurements recorded during ICU monitoring
  • Availability of medication-dose and/or fluid-balance records during ICU monitoring

Exclusion Criteria:

  • Age younger than 18 years
  • Length of stay in the intensive care unit of less than 24 hours
  • Absence of usable blood pressure monitoring data
  • Records with irrecoverable timestamp inconsistencies
  • Insufficient monitoring duration for feature construction and future outcome labeling

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
干预/治疗
Adult Intensive Care Unit Patients
Adult patients admitted to the intensive care unit who are monitored during routine clinical care. Routinely collected non-invasive blood pressure, heart rate, medication-dose, and fluid-balance data will be used for machine learning model development and internal validation. No treatment or clinical intervention will be assigned by the study protocol.
Routinely collected intensive care unit data, including non-invasive blood pressure, heart rate, medication-dose records, and fluid-balance data, will be recorded and analyzed for development and internal validation of a machine learning model. The study does not assign any treatment, medication, device, alarm, or clinical decision.

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
Area Under the Receiver Operating Characteristic Curve for 30-Minute Hypotension Prediction
大体时间:From enrollment through the end of ICU monitoring, up to 4 months
Discriminative performance of the machine learning model for predicting hypotension 30 minutes before its occurrence. Hypotension will be defined as systolic blood pressure below 90 mmHg, mean arterial pressure below 65 mmHg, or diastolic blood pressure below 60 mmHg at a five-minute observation point.
From enrollment through the end of ICU monitoring, up to 4 months

次要结果测量

结果测量
措施说明
大体时间
Area Under the Receiver Operating Characteristic Curve for 5- and 15-Minute Hypotension Prediction
大体时间:From enrollment through the end of ICU monitoring, up to 4 months
Discriminative performance of separate machine learning models for predicting hypotension at 5-minute and 15-minute prediction horizons.
From enrollment through the end of ICU monitoring, up to 4 months
Classification Performance of the Hypotension Prediction Model
大体时间:From enrollment through the end of ICU monitoring, up to 4 months
Classification performance of the machine learning model will be assessed using sensitivity, specificity, positive predictive value, negative predictive value, and F1 score at predefined classification thresholds.
From enrollment through the end of ICU monitoring, up to 4 months

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 (实际的)

2026年3月15日

初级完成 (实际的)

2026年6月30日

研究完成 (实际的)

2026年6月30日

研究注册日期

首次提交

2026年5月31日

首先提交符合 QC 标准的

2026年5月31日

首次发布 (实际的)

2026年6月4日

研究记录更新

最后更新发布 (实际的)

2026年7月9日

上次提交的符合 QC 标准的更新

2026年7月7日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

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

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.

订阅