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临床试验/NCT06333002
NCT06333002已完成不适用

Developing an Optimal Machine Learning Model to Predict ICU Outcome in Patients With Acute Hypoxemic Respiratory Failure

Hospital Universitario de Gran Canaria Doctor Negrín15 个研究点 分布在 1 个国家目标入组 1,241 人开始时间: 2024年3月19日最近更新:
适应症
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
1,241
试验地点
15
主要终点
ICU mortality

研究概览

简要总结

Acute hypoxemic respiratory failure (AHRF) is the most common cause of admission in the intensive care units (UCIs) worldwide. We will assess the value of machine learning (ML) techniques for early prediction of ICU death in 1,241 patients enrolled in the PANDORA (Prevalence AND Outcome of acute Respiratory fAilure) Study in Spain. The study was registered with ClinicalTrials.gov (NCT03145974). Our aim is to evaluate the minimum number of variables models using logistic regression and four supervised ML algorithms: Random Forest, Extreme Gradient Boosting, Support Vector Machine and Multilayer Perceptron.

详细描述

Acute hypoxemic respiratory failure (AHRF) is the most common cause of admission in the intensive care units (UCIs) worldwide. We will assess the value of machine learning (ML) techniques for early prediction of ICU death in AHRF patients on mechanical ventilation (MV). Few studies have investigated the prediction of mortality in patients with AHRF.

For model development, the investigators will extract data for the first 2 days after diagnosis of AHRF from patients included in the de-identified database of the PANDORA cohort. We had a database with 2,000,000 anonymized and dissociated demographics and clinical, data from 1,241 patients with AHRF enrolled in our PANDORA cohort (Prevalence AND Outcome of acute Respiratory fAilure) from 22 Spanish hospitals and coordinated by the principal investigator (JV). The investigators will follow the Transparent reporting of a multivariable prediction model for individual prognosis or diagnosis (TRIPOD) guidelines for model prediction. We will screen collected variables employing a genetic algorithm variable selection method to achieve parsimony. We evaluated the minimum number of variables models using logistic regression and 4 supervised ML algorithms: Random Forest, Extreme Gradient Boosting, Support Vector Machine and Multilayer Perceptron. We will use a 5-fold cross-validation in the dataset of 1,000 patients selected randomly in training data (80%) and testing data (20%). For external validation, we will use the remaining 241 patients.

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

  • endotracheal intubation plus mechanical ventilation (MV)
  • PaO2/FiO2 ratio ≤300 mmHg under MV with positive end-expiratory pressure (PEEP) ≥5 cmH2O and FiO2 ≥0.3.

排除标准

  • Post-operative patients ventilated <24 h
  • Brain death patients.

研究组 & 干预措施

Validation cohort

It will contain 200 patients randomly selected (20% of 1000 patients with AHRF

干预措施: machine learning analysis (Other)

Confirmatory cohort

It will contain the remaining 241 patients randomply selected (por external validation)

干预措施: machine learning analysis (Other)

Derivation cohort

It will contain 800 patients randomly selected (1,000 patients with AHRF)

干预措施: machine learning analysis (Other)

结局指标

主要结局

ICU mortality

时间窗: up to 100 weeks (from inclusion to death or diascharge from intensive care unit

death in the intensive care unit

次要结局

  • MV duration(up to 100 weeks (from inclusion to extubation))

研究者

发起方
Hospital Universitario de Gran Canaria Doctor Negrín
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jesus Villar

principal investigator

Hospital Universitario de Gran Canaria Doctor Negrín

研究点 (15)

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