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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  
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 
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  
Status 
Not Applicable 
 
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.

 
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