| 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
|
|
|
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
|
|
|
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. |