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临床试验/NCT05993377
NCT05993377已完成不适用

Predicting Length of Mechanical Ventilation in Moderate-to-severe Acute Respiratory Distress Syndrome Using Machine Learning

Dr. Negrin University Hospital20 个研究点 分布在 2 个国家目标入组 1,303 人开始时间: 2023年8月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,303
试验地点
20
主要终点
Days on mechanical ventilation

研究概览

简要总结

The investigators are planning to perform a secondary analysis of an academic dataset of 1,303 patients with moderate-to-severe acute respiratory distress syndrome (ARDS) included in several published cohorts (NCT00736892, NCT022288949, NCT02836444, NCT03145974), aimed to characterize the best early scenario during the first three days of diagnosis to predict duration of mechanical ventilation in the intensive care unit (ICU) using supervised machine learning (ML) approaches.

详细描述

The acute respiratory distress syndrome (ARDS) is an important cause of morbidity, mortality, and costs in intensive care units (ICUs) worldwide. Most ARDS patients require mechanical ventilation (MV). Few studies have investigated the prediction of MV duration of ARDS.

For model description and testing, the investigators will extract data from he first three ICU days after diagnosis of moderate-to-severe ARDS from patients included in the de-identified database, which includes 1,000 mechanically ventilated patients enrolled in several observational cohorts in Spain, coordinated by the principal investigator (JV), and funded by the Instituto de Salud Carlos III (ISCIII). The investigators will follow the TRIPOD guidelines and machine learning techniques will be implemented [Random Forest (RF), eXtreme Gradient Boosting (XGBoost), and Logistic regression analysis) for the development and accuracy of prediction models. Disease progression will be tracked along those 3 ICU days to assess lung severity according to Berlin criteria. For external validation, the investigators will use 303 patients enrolled in a contemporary observational study (NCT03145974). The investigators will evaluate the accuracy of prediction models by calculation several statistics, such as sensitivity, specificity, positive predictive value, negative value for each model. The investigators will select the best early prediction model with data captured on the 1st, 2nd, or 3rd day.

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 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Berlin criteria for moderate to severe acute respiratory distress syndrome

排除标准

  • •Postoperative patients ventilated <24h
  • •brain death patients

结局指标

主要结局

Days on mechanical ventilation

时间窗: from diagnosis to extubation

Duration of mechanical ventilation

次要结局

  • ICU mortality(up to 24 weeks)

研究者

发起方
Dr. Negrin University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jesus Villar

principal investigator

Dr. Negrin University Hospital

研究点 (20)

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