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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: E668||Other obesity, |
|
Intervention / Comparator Agent
|
|
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 |