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
|
|
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
|
|
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.
|