跳至主要内容
临床试验/NCT05886803
NCT05886803招募中不适用

Prediction of the Spontaneous Breathing Test Success Using Biosignal and Biomarker in Critical Care Unit by a Machine Learning Approach

Centre Hospitalier Universitaire de Nice2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2023年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
500
试验地点
2
主要终点
Prediction of the spontaneous breathing test outcome.

研究概览

简要总结

Context:

Several authors have been interested in applying Artificial Intelligence (AI) to medicine, using various Machine Learning (ML) techniques: managing septic shock, predicting renal failure... [1, 2] AI has an important place in decision support for clinicians [3]. The weaning period is a really important time in the management of a patient on mechanical ventilation and can take up to half of the time spent in intensive care unit. The first weaning attempt is unsuccessful in 20% of patients However, mortality can be as high as 38% in patients with the most difficult weaning [4]. Only a few studies have looked at the application of machine learning in this area, and only one has looked at the use of biosignals (cardiac rate, ECG, ventilatory parameters…) [5-7]. To improve morbidity, mortality and reduce length of stay, it is essential to be able to predict the success of the spontaneous breathing test and extubation.

Investigators propose to develop a predictive algorithm for the success of a ventilatory weaning test based on biosignal records and others features.

Methods:

It is a critical care, oligo-centric and retrospective study the investigators included biosignal variables extracted from the electronic medical record, such as respiratory (RR, minute volume...), cardiac (systolic pressure, heart rate...), ventilator parameters and other discrete variables (age, comorbidity...). Most biosignal variables are minute-by-minute records. Recording starts 48 hours before the test and stops at the start of the weaning test. The investigators extracted features from these records, combined them with other biomarkers, and applied several machine learning algorithms: Logistic Regression, Random Forest Classifier, Support Vector Classifier (SVC), XGBoost, and Light Gradient Boosting Method (LGBM)…

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Computerized health report (CHR)
  • Spontaneous breathing test should have been performed

排除标准

  • Spontaneous breathing test has not been performed,
  • Biosignal (cardiac, respiratory) are not registered in the CHR
  • Patient died before the spontaneous breathing test
  • Opposition to the study has been expressed.

研究组 & 干预措施

Spontaneous Breathing Test

The first group will be composed only by patients admitted in intensive care/critical care for ventilation support, and who successed the spontaneous breathing test.

干预措施: Spontaneous ventilation test (Other)

Non Spontaneous Breathing Test

The second group will be composed only by patients admitted in intensive care/critical care for ventilation support, and who failed the spontaneous breathing test.

干预措施: Spontaneous ventilation test (Other)

结局指标

主要结局

Prediction of the spontaneous breathing test outcome.

时间窗: 2 years

Two modalities of test are performed in clinical : either a T-tube test or a spontaneous ventilation test at low level of Inspiratory Support and PEEP (7AI 4PEEP, 7Ai 0PEEP). A successful weaning test is defined by the absence of the following criteria at the end of the test: (i) increase in respiratory rate \> 35cpm, (ii) SpO2 \<90%, (iii) change of more than 20% in heart rate or blood pressure, (iv) modification of consciousness.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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