| CTRI Number |
CTRI/2026/01/101947 [Registered on: 23/01/2026] Trial Registered Prospectively |
| Last Modified On: |
23/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of exercise test to assess fitness before major elective surgery |
|
Scientific Title of Study
|
Fitness First, Surgery second,a pilot study on the role of Cardiopulmonary Exercise Testing (CPET) in Preoperative risk assessment. |
| Trial Acronym |
cardiopulmonary exercise testing |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
uppala sirisha |
| Designation |
Dnb Anaesthesia |
| Affiliation |
AIG HOSPITALS |
| Address |
Department of anaesthesia and perioperative critical care,AIG HOSPITALS,mindspace,gachibowli
Fourth floor,OT complex,Anaesthesia department of perioperative medicine and critical care,Aig hospitals,Gachibowli
Hyderabad
TELANGANA
500081
India |
| Phone |
09491502447 |
| Fax |
|
| Email |
Siri936@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.sneha eda |
| Designation |
consultant anaesthesia |
| Affiliation |
AIG HOSPITALS |
| Address |
AIG HOSPITALS,Mindspace,Gachibowli
4 TH FLOOR,OT COMPLEX ,DEPARTMENT OF ANAESTHESIA AND PERIOPERATIVE CRITICAL CARE ,GACHIBOWLI
Hyderabad
TELANGANA
500032
India |
| Phone |
9655535271 |
| Fax |
|
| Email |
snehaeda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
uppala sirisha |
| Designation |
dnb anaesthesia |
| Affiliation |
AIG HOSPITALS |
| Address |
AIG HOSPITALS,Mindspace,Gachibowli
4 TH FLOOR,OT COMPLEX ,DEPARTMENT OF ANAESTHESIA AND PERIOPERATIVE CRITICAL CARE ,GACHIBOWLI
Hyderabad
TELANGANA
500081
India |
| Phone |
09491502447 |
| Fax |
|
| Email |
Siri936@gmail.com |
|
|
Source of Monetary or Material Support
|
| ASIAN INSTITUTE OF GASTROENTEROLOGY HOSPITALS,500032,INDIA |
|
|
Primary Sponsor
|
| Name |
AIG HOSPITALS |
| Address |
AIG HOSPITALS GACHIBOWLI HYDERABAD 500032 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Druppala sirisha |
Aig hospitals |
fourth floor,ot complex,anaesthesia department,Gachibowli
Hyderabad
TELANGANA |
9491502447
siri936@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ASIAN INSTITUTE OF GASTROENTEROLOGY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Age between 18 and 75 years
ASA Physical Status 1 ,2
Scheduled for elective major surgery
No known contraindications for CPET
|
|
| ExclusionCriteria |
| Details |
ASA 3 and above
Emergency surgeries
Severe cardiopulmonary disease precluding CPET
Unstable angina or recent myocardial infarction less than 6 weeks
Severe aortic stenosis
Neuromuscular disorders affecting exercise performance
Inability to provide informed consent
Anaemia less than 10
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| • Incidence of postoperative complications (cardiac, pulmonary) within 30 days, correlated with CPET parameters. |
WITH IN 30 DAYS AFTER SURGERY |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Lenght of icu stay,Lenth of hospital stay,Reexploration |
With in 30 days post surgery |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
03/02/2026 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This is a single centre prospective pilot study to evaluate the role of cardiopulmonary exercise testing in preoperative risk assessment and optimization of patients undergoing major surgery. The study aims to assess whether CPET derived parameters such as VO2 peak, anaerobic threshold, and ventilatory efficiency can help in predicting postoperative cardiac and pulmonary complications. Patients scheduled for elective major surgery will be recruited. Findings from this study may provide evidence for incorporating CPET into routine preoperative assessment and help in improving surgical outcomes.
|