| CTRI Number |
CTRI/2026/04/108844 [Registered on: 20/04/2026] Trial Registered Prospectively |
| Last Modified On: |
20/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two methods of optimizing ventilation during general anaesthesia using PEEP in adult females undergoing laparoscopic gynaecological surgeries |
|
Scientific Title of Study
|
Comparison of Individualised PEEP Using Lung Compliance versus Body Mass Index in Laproscopic Gynaecological surgery:
A Randomized Controlled Trial |
| 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 Sakshi Duggal |
| Designation |
Assistant Professor |
| Affiliation |
All India institute of medical sciences, New Delhi |
| Address |
Room no. 441, Surgical Block, Department of Anaesthesia, Pain Medicine & Critical Care. All India Institute of Medical Sciences, Ansari Nagar, New Delhi
Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
9911343428 |
| Fax |
|
| Email |
drsakshiduggal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sakshi Duggal |
| Designation |
Assistant Professor |
| Affiliation |
All India institute of medical sciences |
| Address |
Room no. 441, Surgical Block, Department of Anaesthesia, Pain Medicine & Critical Care, All India Institute of Medical Sciences, Ansari Nagar, New Delhi - 110029
South
DELHI
110029
India |
| Phone |
9911343428 |
| Fax |
|
| Email |
drsakshiduggal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dhilip Kumar E |
| Designation |
Junior resident |
| Affiliation |
All India institute of medical sciences |
| Address |
Department of Anaesthesiology, Pain medicine & Critical Care,
All India Institute of Medical Sciences, Ansari Nagar, New Delhi - 110029
South
DELHI
110029
India |
| Phone |
7708960617 |
| Fax |
|
| Email |
dhilipkumarezhilarasan14@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Ansari Nagar, New Delhi - 110029 |
|
|
Primary Sponsor
|
| Name |
All India institute of medical sciences |
| Address |
All India Institute of Medical Sciences, Ansari Nagar, New Delhi - 110029 |
| Type of Sponsor |
Research institution |
|
|
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 Dhilip Kumar E |
All India Institute of Medical Sciences, New Delhi |
Department of Anaesthesia, Pain Medicine & Critical Care, Main building, 5th floor, All India Institute of Medical Sciences, Ansari Nagar, New Delhi - 110029
South
DELHI |
7708960617
dhilipkumarezhilarasan14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee for post graduate research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C579||Malignant neoplasm of female genital organ, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BMI based PEEP |
PEEP setting in the intervention arm would be done as per the BMI of the patient. this is the new proposed method, being compared to the standard of care technique for PEEP, i.e. compliance based PEEP. the intervention would be done only while mechanically ventilating the patient intra-operatively. |
| Comparator Agent |
Compliance based PEEP |
PEEP is set as per the lung compliance of the patient, this being the standard of care has been taken as a comparator in the trial. The intervention would be done only during mechanically ventilating the patient during general anaesthesia intraoperatively. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
ASA Physical Status I or II or III
BMI 18 - 40 Kg/m2
Scheduled for elective laparoscopic gynecological surgery under general anaesthesia.
Informed consent
|
|
| ExclusionCriteria |
| Details |
Pre- existing lung disease (COPD, ARDS, fibrosis)
Pregnancy
Emergency or open surgery
MAP less than 65 mmHg or need for vasopressors prior to induction
Contraindication to PEEP ( eg., pneumothorax, severe pulmonary hypertension)
Refusal or inability to provide informed consent
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the mean intraoperative driving pressure between Compliance titrated PEEP and BMI- based PEEP |
Every 30 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare lung aeration using Lung Ultrasound Score(LUS).
To measure perioperative respiratory complian(Crs)
To evaluate intraoperative haemodynamic stability including mean arterial pressure (MAP), vasopressors requirement
To assess perioperative oxygenation parameters including postoperative SpO², PaO², PaO²/FiO² ratio.
To identify the incidence of postoperative pulmonary complications(PPCs).
|
Every 30 minutes intraoperatively
And 30 minutes after postoperative |
|
|
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)
|
03/05/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
03/05/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
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
|
This randomized controlled trial will compare individualized positive end-expiratory pressure (PEEP) titrated using lung compliance with BMI-based PEEP during elective laparoscopic gynaecological surgery under general anaesthesia. Laparoscopic procedures with pneumoperitoneum and Trendelenburg positioning impair respiratory mechanics and may increase driving pressure atelectasis, and postoperative pulmonary complications. There is currently no consensus on the optimal method to select intraoperative PEEP.
A total of 60 adult female patients will be randomized into two groups. Group C will receive individualized PEEP identified by an incremental–decremental PEEP titration aimed at achieving the lowest driving pressure. Group B will receive BMI-based PEEP. Standardized anaesthesia, ventilation settings, and intraoperative monitoring will be used for all participants.
The primary outcome is mean intraoperative driving pressure. Secondary outcomes include respiratory compliance lung aeration measured by Lung Ultrasound Score oxygenation parameters haemodynamic stability, and incidence of postoperative pulmonary complications. The study aims to determine whether compliance-guided individualized PEEP improves intraoperative respiratory mechanics and postoperative lung aeration compared to BMI-based PEEP |