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CTRI Number  CTRI/2025/03/081516 [Registered on: 03/03/2025] Trial Registered Prospectively
Last Modified On: 24/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Identifying post operative lung complications after abdomen surgery using six minute walk test  
Scientific Title of Study   Evaluation of Six-Minute walk test in predicting post operative pulmonary complication in major abdominal surgeries- An Observational study 
Trial Acronym  6MWT- six minute walk test 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nivetha Baskaran 
Designation  post graduate  
Affiliation  SRM MEDICAL COLLEGE AND RESEARCH INSTITUTE 
Address  room no 6, second floor, department of anesthesia,srm medical college, srm nagar kattangulathur chengalpattu, tamil nadu
room no 6, second floor, department of anesthesia,srm medical college, srm nagar kattangulathur chengalpattu, tamil nadu
Kancheepuram
TAMIL NADU
603203
India 
Phone  9445094799  
Fax    
Email  nivedastar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Venkatraman 
Designation  professor 
Affiliation  SRM MEDICAL COLLEGE 
Address  room no 6, second floor, department of anesthesia, srm medical college, srm nagar kattangulathur chengalpattu, tamil nadu
room no 6, second floor, department of anesthesia, srm medical college, srm nagar kattangulathur chengalpattu, tamil nadu
Kancheepuram
TAMIL NADU
603203
India 
Phone  9894581455  
Fax    
Email  drvenkat94@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Venkatraman 
Designation  professor 
Affiliation  SRM MEDICAL COLLEGE 
Address  room no 6, second floor, department of anesthesia, srm medical college, srm nagar kattangulathur chengalpattu, tamil nadu
room no 6, second floor, department of anesthesia, srm medical college, srm nagar kattangulathur chengalpattu, tamil nadu
Kancheepuram
TAMIL NADU
603203
India 
Phone  9894581455  
Fax    
Email  drvenkat94@gmail.com  
 
Source of Monetary or Material Support  
self 
 
Primary Sponsor  
Name  SRM MEDICAL COLLEGE 
Address  SRM MEDICAL COLLEGE, SRM NAGAR, KATTANGULATHUR,CHENGALPATTU 603203 
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 
NIVETHA BASKARAN  SRM MEDICAL COLLEGE HOSPITAL  ROOM NO 6, SECOND FLOOR, DEPARTMENT OF ANESTHESIA, SRM MEDICAL COLLEGE, SRM NAGAR, KATTANGULATHUR, CHENGALPATTU
Kancheepuram
TAMIL NADU 
9445094799

nivedastar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J958||Other intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  ASA PS- 1-3 and surgery duration of more than 2 hours. 
 
ExclusionCriteria 
Details  Patients with pre-existing pulmonary diseases.
Patients with severe cardiac diseases and renal diseases.
Patients with impaired walking (joint muscle pain, paresis, arthritis)
Patients with resting tachycardia, uncontrolled hypertension.
Patients with peripheral vascular diseases.
Pregnancy
Uncooperative Patients. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Correlation between the six-minute walk test and incidence of post-operative pulmonary complications.  48 hours 
 
Secondary Outcome  
Outcome  TimePoints 
1. Length of ICU stay
2. 30 Day mortality rate.
3. Identify the factors such as smoking, age and weight in causing post operative pulmonary complications. 
30 days 
 
Target Sample Size   Total Sample Size="139"
Sample Size from India="139" 
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)   10/03/2025 
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="6"
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 study will be conducted on patients undergoing elective major abdominal surgeries. The written and informed consent will be obtained from all the patients.

One hundred and thirty-nine patients scheduled for elective major abdominal surgeries will be enrolled in this study.

A brief history taking would be done. History of known comorbidities, history of smoking, if a smoker the number of cigarettes per day, the number of years of smoking and the last smoking would be noted.

The six-minute walk test will be performed indoor along a flat surface in a straight corridor 30m long, with 180 degree turns every 30m near the pre-anesthesia clinic. The resuscitation and crash cart equipment will be made available.

The patient’s heart rate, oxygen saturation will be monitored throughout the test.

The patients would be monitored continuously for any adverse reaction throughout the procedure.

The ability of the patients to complete the test will be noted. If the patients are not able to complete the test, then the number of minutes, they are able to walk will be noted.

Patients posted for major abdominal surgeries will be premedicated with T. Alprazolam 0.25mg, T. Ranitidine 150mg and T. Metoclopramide 10mg, the night before surgery and on the morning of the surgery.

The patients posted for major abdominal surgeries will all be administered general anesthesia with epidural anesthesia. Patients in the premedication room will be monitored for the heart rate, blood pressure, oxygen saturation. Patients will be shifted to the operating room. Patients will be premedicated with Inj. Midazolam 0.01-0.02mg/kg and Inj. Fentanyl 2mcg/kg. Then induced with Inj. Propofol 2mg/kg and muscle relaxation with Inj. Vecuronium 0.08-0.12mg/kg. Patients will be intubated with endotracheal tube and depth of anesthesia would be maintained with 50% O2 and 50% N2O and 1 MAC Sevoflurane.

Epidural will be activated intra-operatively with levobupivacaine 0.25% 6-8ml and topped up every 2 hours with 3-6ml.

Patients will be administered Inj. Fentanyl 0.5mcg/kg every hour till the end of surgery. Relaxation will be maintained with vecuronium 0.01mg/kg.

Intra-operatively, the patient’s heart rate, blood pressure, respiratory rate, oxygen saturation will be monitored and noted.

At the end of surgery, patient will be extubated with Neostigmine (0.07 mg/kg) and glycopyrrolate (0.014 mg/kg).

Patient will be shifted to ICU for monitoring and epidural infusion.

Patients with be given 0.125% Levobupivacaine with Fentanyl 2mcg/ml epidural infusion @ 4-6ml/hour postoperatively.

The Patient is said to have post-operative pulmonary complications, if any of the following happens:

>prolonged mechanical ventilation>48hrs

>atelectasis (radiological diagnosis)

>bronchitis

>pneumonia

>acute respiratory failure

>Fall in oxygen saturation (<92% in Room air)

>Patients requiring oxygen support >24hours.

>Development of new history of cough with sputum production.

>Persistent tachypnoea >30 for >24hours.

The results of the test would be documented.

The patients would be monitored for post-operative pulmonary complications during the hospital stay.

The criteria for ICU discharge are:

>Patient should be pain free.

>Hemodynamically stable.

>Urinary catheter removed.

>Patient started on orals.

The length of ICU stay for the patients will also be studied.

The patients would be followed up through phone call every week till 30days.

The correlation between smoking, age and weight and incidence of post-operative pulmonary complications will also be studied.


 
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