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CTRI Number  CTRI/2021/12/038844 [Registered on: 22/12/2021] Trial Registered Prospectively
Last Modified On: 11/11/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   comparison of exercise capacity by two methods (assessment by anesthesiologist and 6minute walk test) in obese patients planned for elective surgery 
Scientific Title of Study   Comparison of Clinician Judgment with 6 Minute Walk Test for Preoperative Functional Capacity Assessment in Obese Patients: A Cross Sectional Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sanjeev G 
Designation  Postgraduate 
Affiliation  Mahatma Gandhi Medical College and Research Institute 
Address  Department of anesthesia, Mahatma Gandhi medical college and research institute, Pillayarkuppam, Pondicherry.
Mahatma Gandhi medical college and research institute, Pillayarkuppam, Pondicherry.
Pondicherry
PONDICHERRY
607402
India 
Phone  9489566571  
Fax    
Email  sanj2645@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrAnnie Sheeba J 
Designation  Associate Professor 
Affiliation  Mahatma Gandhi medical college and research institute 
Address  Department of anesthesia, Mahatma Gandhi medical college and research institute, Pillayarkuppam, Pondicherry.

Pondicherry
PONDICHERRY
607402
India 
Phone  9655035791  
Fax    
Email  dr.anniej@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  DrAnnie Sheeba J 
Designation  Associate Professor 
Affiliation  Mahatma Gandhi medical college and research institute 
Address  Department of anesthesia, Mahatma Gandhi medical college and research institute, Pillayarkuppam, Pondicherry.

Pondicherry
PONDICHERRY
607402
India 
Phone  9655035791  
Fax    
Email  dr.anniej@yahoo.com  
 
Source of Monetary or Material Support  
Mahatma Gandhi Medical college and Research Intitute  
 
Primary Sponsor  
Name  Mahatma Gandhi medical college and research institute 
Address  Mahatma Gandhi medical college and research institute, Pillayarkuppam, Pondicherry 607402. 
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 
Sanjeev G  Department of Anesthesia, Mahatma Gandhi medical college and research institute  2nd floor, Hospital Block Mahatma Gandhi medical college and research institute, Pillayarkuppam, Pondicherry 607402.
Pondicherry
PONDICHERRY 
9489566571

sanj2645@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institional human ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E668||Other obesity,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Age 18-60 years
2.Posted for elective surgery
3. BMI >30 to 40,
4. American physical status 1and 2 
 
ExclusionCriteria 
Details  1. Trauma patients
2.Patient posted for Cardiothoracic and
Neurosurgery
3.physical limitation
4. C/I for physical assessment
5.h/o critical incident in past 30 days
(Accidental fall, recent MI, recent
infection, hospitalization for other reason
apart from the surgical cause 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the functional capacity assessment by Clinician judgment using METS
score versus distance travelled during a 6 Minute Walk Test.
 
baseline 
 
Secondary Outcome  
Outcome  TimePoints 
To correlate the 6 Minute Walk Test parameters with grades of obesity  baseline 
 
Target Sample Size   Total Sample Size="216"
Sample Size from India="216" 
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)   20/01/2022 
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="1"
Months="2"
Days="3" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Preoperative assessment of a patient and risk stratification is vital to reduce the perioperative surgical and anesthetic mortality and morbidity.There are many bedside tests to assess the functional capacity of a patient like 6 min walk test, breath holding test, spirometry, and matchstick blow test. These tests assess both the cardiopulmonary reserve and musculoskeletal system. Studies have shown that 6MWT has good predictive values for postoperative complications and is recommended test where CPET is unavailable.8These simple yet effective predictive tests are not commonly used in clinical practice. Bedside FC tests have been individually compared with various high end and gold standard test like CPET, NT pro-BNP, stress enzymes. To our literary knowledge, no studies have compared the correlation of preoperative bedside FC assessment with the commonly practice clinician judgment in obese patients. Hence, we aim to compare preoperative functional capacity assessment in obese patients undergoing elective non cardiac surgery: Clinician Judgment and 6 Minute Walk Test.
Methodology.
Patient will undergo routine evaluation by the PAC consultant for fitness for anaesthesia. The functional capacity assessment of the recruited will be done by the concerned anesthesiologist in PAC based on various criteria- patient history, METs score, breath holding test. After the clinical examination by the PAC consultant, the METs score 10 assigned by the PAC consultant will be documented and categorized into METs <4, 4-7, >7 indicating poor, normal and good functional capacity.
After the admission of the patient for the proposed elective surgery, the patient will be given a time slot and asked to report to department of anesthesiology preferably without heavy meals. The anesthesiologist blinded to the Functional capacity score assessed in PAC will conduct the 6 MWT. 6 MWT - a measured corridor course will used for walking with subjects instructed to walk from one end to other at their own pace attempting to cover as much distance as possible in the allotted 6 min. Location - a long, flat, straight, enclosed 30 m (100 feet) college corridor marked by cones will be used. The length of the corridor will be marked every 3 m by a color tape. The subject was rested for about 10 min in a chair, located near the starting position, before the test. During this time anthropometric parameters of the subject and the blood pressure were taken. An activity tracker with a pedometer app will be applied on the patient’s wrist. As soon as the subject starts to walk, the timer will be set. Number of laps will be counted each time the subject returns to the starting point. Additional distance covered will also be recorded. The total distance walked, the post-test HR, BP, SPO2 and fatigue index by BORG scale will be recorded
 
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