| CTRI Number |
CTRI/2025/09/093965 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
31/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing personalized breathing support with standard methods to prevent lung collapse during laparoscopic abdominal surgery |
|
Scientific Title of Study
|
Comparison of driving pressure guided individualized PEEP with conventional PEEP in preventing lung atelectasis in patients undergoing laparoscopic abdominal surgery |
| 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 Shalu |
| Designation |
Post graduate resident |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi |
| Address |
Department of anaesthesia and intensive care vardhman mahavir medical college and safdarjung hospital, Ansari nagar, New delhi.
East
DELHI
110029
India |
| Phone |
9205144720 |
| Fax |
|
| Email |
dshalu9998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Udismita Baruah |
| Designation |
Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi |
| Address |
Department of anaesthesia and intensive care vardhman mahavir medical college and safdarjung hospital, Ansari nagar, New delhi.
DELHI
110029
India |
| Phone |
9868996636 |
| Fax |
|
| Email |
udismitabaruah@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Udismita Baruah |
| Designation |
Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi |
| Address |
Department of anaesthesia and intensive care vardhman mahavir medical college and safdarjung hospital, Ansari nagar, New delhi.
East
DELHI
110029
India |
| Phone |
9868996636 |
| Fax |
|
| Email |
udismitabaruah@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman mahavir medical College and safdarjung hospital, New Delhi 110029 |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College and Safdarjung Hospital New Delhi |
| Address |
Ansari nagar east , New Delhi
110029 |
| Type of Sponsor |
Government medical college |
|
|
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 Shalu |
Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi |
Operation theatres, Department of anaesthesia and intensive care vardhman mahavir medical college and safdarjung hospital, Ansari nagar east, 110029 New delhi.
South
DELHI |
9205144720
dshalu9998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vardhman Mahavir Medical College and Safdarjung Hospital ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, (2) ICD-10 Condition: K806||Calculus of gallbladder and bile duct with cholecystitis, (3) ICD-10 Condition: N201||Calculus of ureter, (4) ICD-10 Condition: N852||Hypertrophy of uterus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional PEEP |
Conventional peep will be given to Patients undergoing laparoscopic Abdominal surgery As ventilatory setting . |
| Intervention |
Driving pressure guided Individualized PEEP |
Driving pressure guided Individualized PEEP will be given in ventilator settings during laparoscopic abdominal surgery while maintaining the ventilation in patients undergoing under anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients scheduled for elective laparoscopic abdominal surgery, classified as ASA physical status 1 to 2 |
|
| ExclusionCriteria |
| Details |
1.Candidates with pre existing lung and chest related issues
Like copd, asthma
2. History of pulmonary and thoracic surgery or history of mechanical ventilation within 1 month
3. Known neuromuscular dysfunction
4. Patients with contraindications of PEEP
5. BMI greater than 35 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare postoperative lung atelectasis at 30 minutes post extubation in post anesthesia care unit using lung ultrasound score between two study groups of patient undergoing laparoscopic abdominal surgery |
At 30 minutes of post extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate interoperative mechanical respiratory parameters, including peak airway pressure, peak plateau pressure, dynamic lung compliance. |
After intubation, after establishment of Pneumo peritonium and after Exsufflation of pneumo peritonium. |
| To evaluate intra operative Hemodynamics |
before and after intubation, after establishment of Pneumo peritonium and after Exsufflation of pneumo peritonium. |
| To evaluate biomarkers of inflammation in patient of laparoscopic abdominal surgery |
Before intubation and 30 minutes after intubation. |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
14/09/2025 |
| 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 Yet Recruiting |
| 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
|
In the one patient group we are giving Driving pressure guided individualized peep and Post operative lung atelectasis will be assessed by Lung ultrasound score in Patient’s undergoing Laprooscopic abdominal surgery. |