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CTRI Number  CTRI/2025/05/086616 [Registered on: 09/05/2025] Trial Registered Prospectively
Last Modified On: 08/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective observational 
Study Design  Other 
Public Title of Study   A study to evaluate lung function after major abdominal surgeries 
Scientific Title of Study   Assessment of postoperative lung collapse after major gastrointestinal surgery under general anaesthesia using lung ultrasonography 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
4649_Protocol version 2.0 dated 18/02/2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vijaya Patil 
Designation  Professor and Head 
Affiliation  Tata Memorial Hospital 
Address  Department of Anesthesia, Critical care and Pain, Major OT complex, Second floor, Main Building, Tata Memorial Hospital Dr E Borges Road Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9819883535  
Fax    
Email  vijayappatil@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vijaya Patil 
Designation  Professor and Head 
Affiliation  Tata Memorial Hospital 
Address  Department of Anesthesia, Critical care and Pain, Major OT complex, Second floor, Main Building, Tata Memorial Hospital Dr E Borges Road Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9819883535  
Fax    
Email  vijayappatil@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sandesh Konda 
Designation  Post Graduate Student  
Affiliation  Tata Memorial Hospital 
Address  Department of Anesthesia Critical care and Pain, Major OT complex, Second floor, Main Building, Tata Memorial Hospital Dr E Borges Road Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  8096812860  
Fax    
Email  saisandesh.konda144@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital Dr E Borges Road Parel Mumbai 400012  
 
Primary Sponsor  
Name  Tata Memorial Hospital  
Address  Department of Anesthesia Critical care and Pain, Major OT complex, Second floor, Main Building, Tata Memorial Hospital Dr E Borges Road Parel Mumbai 400012, Maharashtra, India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
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 Vijaya Patil  Tata Memorial Hospital  Department of Anesthesia Critical care and Pain, Major OT complex, Second floor, Main Building, Tata Memorial Hospital Dr E Borges Road Parel Mumbai 400012, Maharashtra, India
Mumbai
MAHARASHTRA 
9819883535

vijayappatil@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tata Memorial Hospital Institutional Ethics Committee-I  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: C00-D49||Neoplasms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  All patients undergoing major gastrointestinal surgery under general Anaesthesia laparoscopic as well as open surgeries. All post operative investigations and monitoring will be noted, patients aged 18 yrs or more 
 
ExclusionCriteria 
Details  Patients posted for thoracic surgeries, Patients posted for surgeries with lung pathologies- COPD, Asthma and restrictive lung disease, patients not willing for the study, patients getting shifted to post operative recovery intubated  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the incidence of postoperative lung collapse using modified lung ultrasound score at 12 hrs after admission to the post operative recovery  at 12 hrs after admission to the post operative recovery 
 
Secondary Outcome  
Outcome  TimePoints 
1)To assess the incidence of post operative lung collapse at 2-3 hours after admission to the post operative recovery, before discharge to the ward if the patient is staying in the recovery room for more than 12 hours
2)To correlate the post operative pain score (NRS) with the degree of lung collapse using modified lung ultrasound score
3) To correlate post operative lung collapse with the immediate post operative pulmonary complications of need for oxygen therapy, post operative pneumonia
 
At 2-3 hours after admission to the post operative recovery, before discharge to the ward if the patient is staying in the recovery room for more than 12 hours  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   19/05/2025 
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="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  

Post operative lung collapse is a common post operative complication after major abdominal Surgery it is due to many factors like inadequate pain relief, inadequate physiotherapy, inabilty to clear secretions.

In this study we will use ultrasound which a common scanning used in post operative period and assess the degree of lung collapse using lung ultrasound and give it a score after dividing the lung into 6 quadrants and we will check for degree of lung collapse at 3 different time intervals 2-3 hrs after admission to recovery, next morning after admission/12 hrs after admission to the recovery room, just prior to discharge to ward if the patient stays for more than 12 hrs in recovery room . in patients with lung collapse just after admission to recovery we will see the degree of change in lung collapse. This will help us assess whether our post operative care like pain relief, chest physiotherapy is adequate for the patients in post operative period or do they need improvement.

 
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