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临床试验/NCT07061548
NCT07061548招募中不适用

Development of an Artificial Intelligence Model for Predicting Intraoperative Changes in Cardiac Output Using Capnography During General Anesthesia

Samsung Medical Center1 个研究点 分布在 1 个国家目标入组 2,005 人开始时间: 2025年7月3日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
2,005
试验地点
1
主要终点
Predictability of algorithm

研究概览

简要总结

Conventional monitoring of cardiac output requires an invasive procedure and an additional device, which can lead to increased risk and cost. Investigators developed an artificial intelligence algorithm to predict intraoperative changes in cardiac output using capnography in patients undergoing surgery under general anesthesia.

详细描述

Anesthesiologists strive to maintain adequate cardiac output during surgery. However, conventional monitoring of cardiac output requires an invasive procedure (risk) and an additional device (cost).

Because most surgeries are performed without any invasive monitors, anesthesiologists must manage the patients without cardiac output information.

However, modern anesthesia machines usually provide capnography, and continuous capnography monitoring can help estimate changes in cardiac output. Therefore, investigators aim to develop an artificial intelligence algorithm to predict intraoperative changes in cardiac output using capnography in patients undergoing surgery under general anesthesia.

Investigators train a model using capnography data (5-minute duration) related to a 20% or greater decrease in cardiac output during the same period. The developed model can provide an alarm for a decrease in cardiac output based on the change in capnography.

研究设计

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

入排标准

年龄范围
19 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Elective surgery under general anesthesia
  • Adult patients (18 < age < 76)
  • Patients who were monitored invasive arterial blood pressure (waveform) and capnography (numeric)

排除标准

  • Emergency surgery
  • Cardiovascular and thoracic surgery
  • Known Asthma and Chronic obstructive pulmonary disease (COPD)
  • Preoperative pulmonary function test (PFT) abnormality over moderate grade
  • Intraoperative monitoring duration less than 30 minutes

结局指标

主要结局

Predictability of algorithm

时间窗: Every time points with interval of 5 minutes during surgery

The performance of the algorithm to predict whether cardiac output has decreased by more than 20% compared to 5 minutes ago. Predictability is estimated by area under the receiver-operating characteristic curve analysis.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Heejoon Jeong

Clinical Assistant Professor

Samsung Medical Center

研究点 (1)

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