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临床试验/CTRI/2025/02/081380
CTRI/2025/02/081380已完成不适用

External validation of Lung USG based Post operative pulmonary complications risk prediction model A prospective study

All India Institute Of Medical Sciences1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年3月5日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
1
主要终点
External validation of a logistic regression model comprised of clinical and lung USG parameters in adult patients undergoing elective or emergency surgery

研究概览

简要总结

Postoperative pulmonary complications (PPCs) are significant sources of morbidity and mortality in surgical patients, contributing to prolonged hospital stays, increased healthcare costs, and decreased quality of life. Accurate prediction and early identification of patients at high risk for developing PPCs are crucial for implementing preventive measures, optimizing perioperative management, and improving patient outcomes [1].

External validation, the process of evaluating model performance on independent datasets from different populations or healthcare settings, is essential for assessing the robustness and reliability of predictive models. It provides valuable insights into model generalizability, potential biases, and limitations, thereby informing clinical decision-making and guiding the implementation of predictive tools into routine practice.

Through comprehensive external validation, this research endeavours to address critical gaps in the current literature, contribute to the evidence base supporting predictive modelling in perioperative care, and ultimately, improve patient outcomes by facilitating early identification and targeted interventions for individuals at high risk of developing postoperative pulmonary complications. The logistic regression model was developed from a departmental project (CTRI/2023/09/058028) and it consists of baseline lung ultrasound aeration score, total leucocyte count, INR, serum albumin and serum creatinine.

 Primary Objective

External validation of a logistic regression model comprised of clinical and lung USG parameters in adult patients undergoing elective or emergency surgery

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 abdominal surgery of duration more than two hours either elective or emergency.

排除标准

  • Refusal to participate.
  • Pregnancy or Postpartum up to 6 weeks Preoperative requirement of mechanical ventilation.
  • Preoperative room air oximetry SaO2 less than 90%, or PaO2 less than 60 mmHg. Patients requiring high doses of vasopressor support (Norepinephrine equivalent more than 0.2 mcg/ kg /min).
  • ASA 5 patients, not expected to live beyond 24 hours.

结局指标

主要结局

External validation of a logistic regression model comprised of clinical and lung USG parameters in adult patients undergoing elective or emergency surgery

时间窗: lung usg will be done in preoperative period ,before giving anaesthesia and postoperative period ,within 24hr

次要结局

  • 1. Comparison of predictive accuracy in different subgroup of patients (elective versus emergency surgery, elderly (age more than 65y) versus younger adults (age below 65y).(Preoperative)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Varsha Yadav

All India Institute of Medical Sciences, New Delhi

研究点 (1)

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