| CTRI Number |
CTRI/2023/08/056843 [Registered on: 23/08/2023] Trial Registered Prospectively |
| Last Modified On: |
17/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Changes in lung and diaphragmatic function in laparoscopic abdominal surgery |
|
Scientific Title of Study
|
Assessment of changes in lung aeration and diaphragmatic function using ultrasonography in laparoscopic abdominal surgery 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 |
Stuti Prajapati |
| Designation |
Resident Anaesthesiologist |
| Affiliation |
Employees State Insurance Cooperation Postgraduate Institute of Medical Sciences and Research |
| Address |
Second floor OT complex , room no. 2238, Department of Anaesthesia,
ESI Hospital Basaidarapur, ring road
West Delhi
110015
Esi basaidarapur Department of Anaesthesia, basaidarapur
New delhi
West
DELHI
110015
India |
| Phone |
8744008412 |
| Fax |
|
| Email |
prajapati.dr.s@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Divya Sethi |
| Designation |
Professor |
| Affiliation |
Employees State Insurance Corporation Postgraduate Institute of Medical Sciences and Research |
| Address |
Second floor OT complex , department of Anaesthesia,
Basaidarapur, ring road
West delhi
110015
India
Esi basaidarapur
New delhi
West
DELHI
110015
India |
| Phone |
9891230700 |
| Fax |
|
| Email |
divyasth@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Stuti Prajapati |
| Designation |
Postgraduate student |
| Affiliation |
ESI PGIMSR |
| Address |
Room no. 2238
Department of Anaesthesia
2nd floor , old building
ESIC-PGIMSR
Basaidarapur, Ring road
Room no. 2238
Department of Anaesthesia
2nd floor , old building
ESIC-PGIMSR
Basaidarapur, Ring road
West
DELHI
110015
India |
| Phone |
8744008412 |
| Fax |
|
| Email |
prajapati.dr.s@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESI Post Graduate Institute of Medical Sciences and Research New Delhi |
|
|
Primary Sponsor
|
| Name |
ESI Post Graduates Institute of Medical Sciences and Research New Delhi |
| Address |
Basaidarapur, Ring road New Delhi-110015 |
| 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 Stuti Prajapati |
ESIC Hospital,Basaidarapur |
Second floor OT , Department of Anaesthesia, ESIC-PGIMSR, Basaidarapur Ring Road,West Delhi
West
DELHI |
8744008412
prajapati.dr.s@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - Employees State Insurance Corporation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K806||Calculus of gallbladder and bile duct with cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I and II
Elective laparoscopic cholecystectomy surgery |
|
| ExclusionCriteria |
| Details |
BMI more than 35
Obstetric patients
History of intra-thoracic procedures |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure the changes in modified LUS score |
Time point A: pre-operative room
Time point B: after intubation
Time point C: after deflation of pneumoperitoneum
Time point D: 30 minutes after the arrival of patients in the recovery room
Time point E: before discharge from the recovery room at 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To measure the changes in diaphragmatic excursion |
Time point A: pre-operative room
Time point D: 30 minutes after the arrival of patients in the recovery room
Time point E: before discharge from the recovery room at 24 hours |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2023 |
| Date of Study Completion (India) |
31/01/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Aim is to study the changes in lung aeration and diaphragmatic function in elective laparoscopic abdominal surgery. Total 40 patients will be enrolled for this study according to inclusion and exclusion criteria. Study is prospective Observational non randomised study Written informed consent will be taken from the patients. All patients will be undergoing ultrasonographic scan of bilateral lung zones and score according to Modified Lung Ultrasound Score at following time points Time point A: pre-operative room Time point B: after intubation Time point C: after deflation of pneumoperitoneum Time point D: 30 minutes after the arrival of patients in the recovery room Time point E: before discharge from the recovery room at 24 hours Diaphragmatic function will be assessed using M- mode of USG at time point A, D and E Primary objectives is to assess the changes in Bilaterally lung aeration score.
|