跳至主要内容
临床试验/CTRI/2024/07/070709
CTRI/2024/07/070709招募中不适用

External Validation of a Machine-Learning derived risk prediction model for Post Operative Pulmonary Complications

Dr. Aumkar Kishore Shah1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2024年7月29日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
400
试验地点
1
主要终点
To externally validate a machine learning model in an independent population for predicting POPC as per Melbourne group scale

研究概览

简要总结

Postoperative pulmonary complications (POPC) are a significant cause of morbidity and mortality following surgery, contributing to prolonged hospital stays and increased healthcare costs.

Machine learning (ML) algorithms have shown promise in predicting POPC risk based on preoperative variables.

However, external validation of these models is essential to evaluate their generalizability and clinical utility.

A recent review found that only a few of the developed scores have been externally validated viz. ARISCAT Score

 Recently, such a model was developed in the department.

The machine learning model performed reasonably well in the internal validation cohort, but the investigators were unable to validate in a large external cohort at that time.

This study will aim to externally validate the developed model, thereby increasing the generalizability of the model and pave the way for further multicentric validations and development of a tool for the routine clinical use adapted to the Indian population.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Undergoing major (duration more than 2hours) abdominal surgery Elective or Emergency.

排除标准

  • Pregnancy Post-partum up to 6 weeks Moribund patients not expected to survive more than 48 hours.

结局指标

主要结局

To externally validate a machine learning model in an independent population for predicting POPC as per Melbourne group scale

时间窗: 2 years

次要结局

  • To validate the model to predict postoperative respiratory failure up to day 7
  • To evaluate the calibration of the model in the external validation dataset(2 years)
  • To explore the performance of the model across different subgroups age gender comorbidity status and type of surgery

研究者

发起方
Dr. Aumkar Kishore Shah
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Aumkar Kishore Shah

AIIMS, New Delhi

研究点 (1)

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