| CTRI Number |
CTRI/2024/10/075590 [Registered on: 21/10/2024] Trial Registered Prospectively |
| Last Modified On: |
11/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
How the 6-Minute Walk Test Can Help Predict Breathing Problems After Major Cancer and Stomach Surgeries: A Study |
|
Scientific Title of Study
|
Performance In 6-Min Walk Test In Prediction Of Postoperative Pulmonary Complication In Major Oncosurgeries And Surgical Gastroentero Surgeries-
A Prospective Observational Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S SATHISH KUMAR |
| Designation |
PG STUDENT |
| Affiliation |
INSTITUTE OF ANAESTHESIOLOGY,MADURAI MEDICAL COLLEGE |
| Address |
NO-249,
Institute Of Anaesthesiology,
Government Rajaji Hospital.
Madurai Medical College,
Alwarpuram, Madurai
Madurai TAMIL NADU 625020 India |
| Phone |
9659847686 |
| Fax |
|
| Email |
Sathishujain@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr S. PRATHEEBA DURAIRAJ MD,DA. |
| Designation |
PROFESSOR. |
| Affiliation |
INSTITUTE OF ANAESTHESIOLOGY,MADURAI MEDICAL COLLEGE |
| Address |
Room No-249,
Institute Of Anaesthesiology,
Government Rajaji Hospital.
Madurai Medical College,
Alwarpuram, Madurai
Madurai TAMIL NADU 625020 India |
| Phone |
9443183984 |
| Fax |
|
| Email |
rajdeep181069@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr S SATHISH KUMAR |
| Designation |
PG STUDENT |
| Affiliation |
INSTITUTE OF ANAESTHESIOLOGY,MADURAI MEDICAL COLLEGE |
| Address |
Room NO -249,
Institute Of Anaesthesiology,
Government Rajaji Hospital.
Madurai Medical College,
Alwarpuram, Madurai
Madurai TAMIL NADU 625020 India |
| Phone |
9659847686 |
| Fax |
|
| Email |
Sathishujain@gmail.com |
|
|
Source of Monetary or Material Support
|
|
Government Rajaji Hospital.
Madurai Medical College,
Alwarpuram, Madurai
Tamil Nadu-625020 |
|
|
Primary Sponsor
|
| Name |
DR S SATHISH KUMAR |
| Address |
INSTITUTE OF ANAESTHESIOLOGY,
GOVERNMENT RAJAJI HOSPITAL,
MADURAI MEDICAL COLLEGE,
MADURAI |
| Type of Sponsor |
Other [SELF] |
|
|
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 S SATHISH KUMAR |
GOVERMENT RAJAJI HOSPITAL , MADURAI MEDICAL COLLEGE, MADURAI |
ROOM NO 217-A,
ASSESSMENT CLINIC,
Institute Of Anaesthesiology,
Government Rajaji Hospital.
Madurai Medical College,
Alwarpuram, Madurai
Tamil Nadu-625020 Madurai TAMIL NADU |
9659847686
sathishujain@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE ,MADURAI MEDICAL COLLEGE,GOVT RAJAJI HOSPITAL ,MADURAI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, (2) ICD-10 Condition: K00-K95||Diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
-History of cardiovascular or pulmonary diseases.
-Serum albumin≤30g/L.
-Chronic smoker and chest X Ray with abnormal lung parenchymal / Chest wall findings.
-ASA PS-II Or III.
|
|
| ExclusionCriteria |
| Details |
-Unstable angina /myocardial infarction/
-Acute coronary syndrome in the previous 6 months
-dyspnoea at rest
-inability to walk
(orthopaedic problems, Cerebrovascular accidents, balance disorders)
-unable to interpret or follow instructions,
-resting tachycardia(HR ≥120 beats per min/uncontrolled hypertension(BP≥180/100mmofHg).
severe pain
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To Assess The Correaltion Between 6 Minute Walk Test & PPC ( Postoperative Pulmonary Complication).
|
To Assess The Correaltion Between 6 Minute Walk Test & PPC ( Postoperative Pulmonary Complication) in postoperative 72 hours
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To Evaluate
The Incidence Of Complications During 6 Minutes Walk test
|
post operative 72 hours |
To Evaluate Haemodynamics Stability During The Test
|
test period |
To Evaluate
3)Incidence of PPC
|
post operative hospital stay |
To evaluate The Impact Of Compounding Factors Like Surgery, Smoking, Respiratory Diseases.
|
test and post operative period |
To Evaluate
Length Of Hospital Stay
|
postoperative stay in hospital |
|
|
Target Sample Size
|
Total Sample Size="150" Sample Size from India="150"
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)
|
01/11/2024 |
| 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="0" 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
|
The Six minute walk test was introduced for pulmonary evaluation mostly after lung resection surgeries. It is easy to perform, inexpensive and does not need special equipment or trained personnel, hence it is recently included in pre- operative evaluation. It gives an assessment of tolerance of daily activities. Oncology patients have several overlapping factors interfering with exercise capacity and multiple risk factors for post operative pulmonary complications. Changes to the respiratory system occur immediately under general anaesthesia. Pulmonary evaluation methods in pre operative period for those at risk are mainly spirometry evaluation of lung function tests ( PFT) and the standard method is cardiopulmonary exercise testing (CPET). The PFT reports often not reliable as it is influenced by interpretation and patient performance, while CPET is a complex procedure requiring specialized equipment’s and expertise. Hence alternative methods of functional capacity assessment like 6MWT , incremental shuttle walk test and stair climbing test are useful. METHODOLOGY: After obtaining informed written consent all 150 patients underwent routine pre operative ,Patients were instructed to walk at their comfortable pace back and forth in the marked track with turn around at either end for a duration of 6 minutes and were informed that they will be allowed to take rest or stop the test incase of discomfort . The test was conducted in a flat , straight hallway 25 metre long where emergency assistance was available along with defibrillator and emergency cart. A stopwatch, measuring tape, portable pulse oximeter probe ,sphygmomanometer and lap counter Digi Smart Watch were used. The test was stopped if patient experienced any chest pain ,intolerable dyspnea, leg cramps, diaphoresis, pale appearance and medical assistance was given. Before and after the test , the patient’s BP, HR,SPO2 and Borg dyspnea scores were noted. Further the patient’s underwent surgery as planned under general anaesthesia plus epidural anaesthesia and received the routine postoperative care and multi modal analgesia, using epidural analgesia. The occurence of pulmonary complications during post operative period was noted down until discharge from hospital. The PPC included the following: Prolonged mechanical ventilation >48 hours, Atelectasis, Bronchitis, Bronchospasm, ARDS, Pneumonia, Exacerbation of chronic lung disease , respiratory failure. |