| CTRI Number |
CTRI/2026/02/103988 [Registered on: 16/02/2026] Trial Registered Prospectively |
| Last Modified On: |
16/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
This study looks at two methods of setting a breathing machine during anaesthesia to find out which one keeps the lungs more open during gallbladder surgery |
|
Scientific Title of Study
|
A study to evaluate fixed moderate PEEP versus driving pressure guided PEEP to prevent pulmonary atelectasis in patients undergoing laparoscopic cholecystectomy under general anaesthesia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Preeti gehlaut |
| Designation |
Professor |
| Affiliation |
PGIMS Rohtak |
| Address |
Department of Anaesthesiology and Critical care,PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8950285434 |
| Fax |
|
| Email |
Preeti.gehlaut@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Riya bose |
| Designation |
Junior resident |
| Affiliation |
PGIMS rohtak |
| Address |
Department of Anaesthesiology and Critical care,PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8595679131 |
| Fax |
|
| Email |
Riyabose506@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Riya bose |
| Designation |
Junior resident |
| Affiliation |
PGIMS rohtak |
| Address |
Department of Anaesthesiology and Critical care,PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8595679131 |
| Fax |
|
| Email |
Riyabose506@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology Pt BD Sharma PGIMS Rohtak |
| Address |
Pt.B.D.Sharma PGIMS UHS rohtak HARYANA 124001 |
| 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 |
| Riya Bose |
Department of anaesthesia PGIMS Rohtak |
2nd floor Department of Anaesthesiology new modular ot complex
PGIMS ROHTAK
Rohtak
HARYANA |
8595679131
Riyabose506@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical ethics research committee, PGIMS Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
driving pressure guided PEEP to patients undergoing laparoscopic cholecystectomy |
Group DP: Patients (n=30) will be ventilated with driving pressure based PEEP.Lung
ultrasound will be done in preoperative and postoperative period to note the findings |
| Comparator Agent |
Fixed moderate peep |
Group FP: Patients (n=30) will be ventilated with PEEP 5cm H20 Group. Ultrasound to be done in preoperative and postoperative period to note the findings. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2 patients undergoing laparoscopic cholecystectomy |
|
| ExclusionCriteria |
| Details |
Refusal by patient,
History of COPD or asthma,
History of other significant respiratory disease,
History of any cardiac illness
ASA grade 3 or higher,
BMI more than 35 kg/m2.
Significant medical disease.
Any life-threatening medical complication |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
To measure change in lung ultrasound score (LUS) for pulmonary
atelectasis in patients of laparoscopic cholecystectomy surgeries under general anaesthesia
with moderate and driving pressure guided positive end expiratory pressures |
0min, 10min, 20min, 40min, 60min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The LUS score will be used to determine the amount of aeration loss. |
A basic grading system will be used to provide a score of 0-3 to each of the 12 quadrants. The lung ultrasound score (LUS) will be calculated at preoperative and post operative of all subjects. Each of the 12 quadrants was assigned a score of 0 to 3 according to a simple grading system: O - normal lung sliding with fewer than three single B lines; 1- three or more single B lines; 2-coalescent B lines; and 3 - consolidated lung. The LUS score (0-36) will be determined by summing the scores from each of the 12 quadrants, with larger values indicating more severe aeration loss. |
|
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Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
27/02/2026 |
| 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
|
This study evaluates whether driving pressure–guided positive end-expiratory pressure (PEEP) is more effective than fixed moderate PEEP in preventing pulmonary atelectasis during laparoscopic cholecystectomy under general anesthesia. Laparoscopic surgery and pneumoperitoneum increase the risk of perioperative atelectasis, which can worsen postoperative outcomes. Lung ultrasound (LUS) is used for early detection and quantification of atelectasis. In this randomized interventional study, ASA I–II adults are assigned to fixed PEEP or individualized driving pressure–guided PEEP. Primary outcomes include changes in LUS score, while secondary outcomes assess oxygenation, ventilatory, and hemodynamic parameters.
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