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临床试验/CTRI/2025/02/080524
CTRI/2025/02/080524
尚未招募
不适用

A prospective observational study to assess the impact of perioperative variable in predicting postoperative morbidity and mortality

SRM institute of science and technology1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2025年3月21日最近更新:

概览

阶段
不适用
状态
尚未招募
入组人数
1,000
试验地点
1
主要终点
This score can be used in clinical practice to identify high-risk patients and tailor peri-operative care accordingly

概览

简要总结

Introduction: Multiple factors influence postoperative morbidity and mortality in patients. Therefore, this study will assess all preoperative risk factors, intraoperative variables, and postoperative outcomes, including patient vitals such as heart rate (HR), blood pressure (BP), and oxygen saturation (SpO2). However, the precise correlations between these factors have not been defined. This study aims to develop a scoring system to enhance our understanding of the relationship between these specific perioperative variables and postoperative morbidity and mortality, with the ultimate goal of improving the postoperative outcome

Aim and objective:To develop a preoperative scoring system to predict postoperative morbidity and mortality. Examine the demographic characteristics with co-morbidities of all patients admitted to SRM Hospital for elective and emergency surgeries. To find out the correlation between postoperative morbidity and mortality with several perioperative variables among the patients. Additionally, we intend to develop a scoring system based on these identified risk factors. To validate the newly developed scoring system.

Methodology:

"Examine the demographic characteristics with co-morbidities of all patients admitted to SRM Hospital for elective and emergency surgeries. :A standardized data collection form will be developed All patient details with comorbidities will be recorded from the patient and the anesthesia record sheet by the principal investigator. Data will be analyzed using frequency distribution

To find out the correlation between postoperative morbidity and mortality with several perioperative variables among patients undergoing elective and emergency surgery during the study period. Additionally, we intend to develop a scoring system based on these identified risk factors:Collecting data from patient records, the entire demographic with comorbidities (collection of all the dates from admission to discharge ) Period, and p-value. We get the specific factors that correlate with the outcomes for patients. Correlation of every individual factor with the  outcome (morbidity@ mortality)  and develop the scoring system through equation-multivariate regression  Develop a scoring system based on identified risk factors to assess the predictive value for postoperative outcomes.

To validate the newly developed scoring system: This will be implemented in patients through the prospective observational pilot study.The sample population will consist of patients undergoing elective and emergency surgeries at SRM Hospital who were not included in the previous study. The sample population will be categorized into low risk, moderate risk, and high risk based on the developed score system in the preoperative period. Patient outcome will be monitored Morbidity and mortality will be observed  6 weeks of the postoperative period Patients who have been discharged will be followed through the telephone method for a period of 1 year to observe for mortality and return to normal state.

Expected outcome

we developed a risk stratification score with high predictive accuracy.This score can be used in clinical practice to identify high-risk patients and tailor peri-operative care accordingly. Implementing these findings could potentially reduce post-operative complications and improve patient outcomes.“By focusing on these potential outcomes and conclusions, the study can provide valuable insights into how peri-operative variables influence patient outcomes and help guide future clinical practices.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • Elective And Emergency Surgery Non-cardiac Surgeries ASA I-IV Above 18 – 85 Years Both Sexes.

排除标准

  • Patient Refusal Organ Transplant Surgeries Pregnant Patients.

结局指标

主要结局

This score can be used in clinical practice to identify high-risk patients and tailor peri-operative care accordingly

时间窗: This score can be used in clinical practice to identify high-risk patients and tailor peri-operative care accordingly

次要结局

  • Implementing these findings could potentially reduce post-operative complications & improve patient outcomes.

研究者

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

Uma Maheshwari Mahendran

SRM institute of science and technology

研究点 (1)

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