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CTRI Number  CTRI/2025/02/080524 [Registered on: 13/02/2025] Trial Registered Prospectively
Last Modified On: 23/01/2025
Post Graduate Thesis   
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   To Develop Scoring System In Predicting Surgery And Anaesthesia Outcome 
Scientific Title of Study   A prospective observational study to assess the impact of perioperative variable in predicting postoperative morbidity and mortality  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Uma Maheshwari Mahendran 
Designation  Lecturer 
Affiliation  SRM institute of science and technology  
Address  SRM institute of science and technology Anaesthesia department Kattankulathur Chengalpattu district
SRM institute of science and technology Anaesthesia department Kattankulathur chengalpattu district
Chennai
TAMIL NADU
603203
India 
Phone  9025160806  
Fax    
Email  umamahem3@srmist.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr. R. Venkatraman  
Designation  professor department of Anaesthesiology  
Affiliation  SRM institute of science and technology  
Address  SRM institute of science and technology Kattankulathur chengalpattu district Tamil nadu
SRM institute of science and technology Kattankulathur chengalpattu district
Chennai
TAMIL NADU
603203
India 
Phone  9025160806  
Fax    
Email  umamahem3@srmist.edu.in  
 
Details of Contact Person
Public Query
 
Name  Uma Maheshwari Mahendran 
Designation  Lecturer 
Affiliation  SRM institute of science and technology  
Address  SRM institute of science and technology Anaesthesia department Kattankulathur chengalpattu district
SRM institute of science and technology Anaesthesia department Kattankulathur chengalpattu district
Chennai
TAMIL NADU
603203
India 
Phone  9025160806  
Fax    
Email  umamahem3@srmist.edu.in  
 
Source of Monetary or Material Support  
SRM institute of science and technology, SRM Nagar Kattankulathur campus, Tamil Nadu pincode-603203  
 
Primary Sponsor  
Name  SRM institute of science and technology 
Address  SRM institute of science and technology kattankulathur campus pincode-603203 potheri Chengalpattu district  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Venkatraman   SRM institute of science and technology   SRM institute of science and technology Anaesthesia department, SRM Nagar, Kattankulathur campus pincode-603203
Chennai
TAMIL NADU 
09025160806

umamahem3@srmist.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRM Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details 
Elective And Emergency Surgery
Non-cardiac Surgeries
ASA I-IV
Above 18 – 85 Years
Both Sexes
 
 
ExclusionCriteria 
Details  Patient Refusal
Organ Transplant Surgeries
Pregnant Patients
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
This score can be used in clinical practice to identify high-risk patients and tailor peri-operative care accordingly  This score can be used in clinical practice to identify high-risk patients and tailor peri-operative care accordingly 
 
Secondary Outcome  
Outcome  TimePoints 
Implementing these findings could potentially reduce post-operative complications & improve patient outcomes.
 
2weeks 
 
Target Sample Size   Total Sample Size="1000"
Sample Size from India="1000" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   21/03/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

 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.

 

 
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