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临床试验/NCT05611177
NCT05611177已完成不适用

Predicting Mortality in Patients With the Acute Respiratory Distress Syndrome Using Machine Learning

Dr. Negrin University Hospital3 个研究点 分布在 1 个国家目标入组 1,303 人开始时间: 2022年11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
3
主要终点
ICU mortality

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, NCT02288949, NCT02836444, NCT03145974), aimed to characterize the best early model to predict duration of mechanical ventilation and mortality in the intensive care unit (ICU) after ARDS diagnosis using machine learning approaches.

详细描述

The acute respiratory distress syndrome (ARDS) is a severe form of acute hypoxemic respiratory failure in Critical Care Units worldwide. Most ARDS patients requiere mechanical ventilation (MV). Few studies have investigated the prediction of MV duration and mortality of ARDS.

For model description, the investigators will extract data from the first two ICU days after diagnosis of moderate-to-severe ARDS from patients included in the de-identified database, which includes 1,303 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 tecniques will be implemented (Random Forest, XGBoost, Logistic regression analysis, and/or neural networks) for development of the prediction model, and the accuracy will be compared to those of existing scoring systems for assessing ICU severity (APACHE II, SOFA) and the PaO2/FiO2 ratio. 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 calculating the respective confusion matrices and several statistics such as sensitivity, specificity, positive predictive value, and negative predictive value for mortality and duration of MV. Investigators will select the best probabilistic model with a minimum number of clinical variables.

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

入选标准

  • Berlin criteria for moderate to severe ARDS

排除标准

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

结局指标

主要结局

ICU mortality

时间窗: up to 6 months

mortality in the intensive care unit

次要结局

  • MV duration(from ARDS diagnosis to extubation)

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 (3)

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