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临床试验/NCT07627607
NCT07627607已完成不适用

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

Kutahya Health Sciences University1 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2026年3月15日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
107
试验地点
1

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Routine ICU Data Collection (Other)

研究者

发起方
Kutahya Health Sciences University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Serkan TELLİ

Assistant Professor of Anesthesiology and Reanimation

Kutahya Health Sciences University

研究点 (1)

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