| CTRI Number |
CTRI/2026/01/101320 [Registered on: 16/01/2026] Trial Registered Prospectively |
| Last Modified On: |
13/01/2026 |
| 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
|
A Study of Ventilatory Recruitment Maneuvers in Patients Undergoing Laparoscopic Surgery under General Anesthesia Using PCV-VG Mode |
|
Scientific Title of Study
|
Analysis of Different Ventilatory Recruitement Maneuvers in Patients Undergoing Laparoscopic Surgeries under General Anaesthesia using PCV-VG Mode : A Prospective Randomized Controlled 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 |
Dr Bhumika Pathak |
| Designation |
Professor of Department of Anaesthesiology |
| Affiliation |
SHREE KRISHNA HOSPITAL AND PRAMUKH SWAMI MEDICAL COLLEGE |
| Address |
112,Department of Anaesthesiology, H.M. Patel Centre for Medical Care and Education, Karamsad, Anand, Gujarat-388325, India
Anand
GUJARAT
388325
India |
| Phone |
9904438877 |
| Fax |
|
| Email |
docbhum29@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhumika Pathak |
| Designation |
Professor of Department of Anaesthesiology |
| Affiliation |
SHREE KRISHNA HOSPITAL AND PRAMUKH SWAMI MEDICAL COLLEGE |
| Address |
112,Department of Anaesthesiology, H.M. Patel Centre for Medical Care and Education, Karamsad, Anand, Gujarat-388325, India
Anand
GUJARAT
388325
India |
| Phone |
9904438877 |
| Fax |
|
| Email |
docbhum29@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahima Ganvit |
| Designation |
Resident Doctor of Department of Anaesthesiology |
| Affiliation |
SHREE KRISHNA HOSPITAL AND PRAMUKH SWAMI MEDICAL COLLEGE |
| Address |
112,Department of Anaesthesiology, H.M. Patel Centre for Medical Care and Education, Karamsad, Anand, Gujarat-388325, India
Anand
GUJARAT
388325
India |
| Phone |
9913387243 |
| Fax |
|
| Email |
mahimaganvit19@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree Krishna hospital, Pramukh swami medical college,Karamsad-388325, Anand, Gujarat,India |
|
|
Primary Sponsor
|
| Name |
Shree Krishna Hospital Pramukh Swami Medical College |
| Address |
Shree Krishna Hospital,Pramukh Swami Medical College, Karamsad-388325, Anand, Gujarat,India |
| Type of Sponsor |
Private 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 Bhumika Pathak |
Shree Krishna Hospital |
112,Department of Anaesthesiology, H.M. Patel Centre for Medical Care and Education, Karamsad, Anand, Gujarat-388325, India
Anand
GUJARAT |
9904438877
docbhum29@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE-2 Bhaikaka University,Karamsad,Anand,Gujarat-388325 |
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 |
| Comparator Agent |
Ventilatory Recruitment Maneuver- Stepwise Incremental |
A stepwise incremental recruitment maneuver will be performed by gradually increasing airway pressure in a stepwise manner with predefined pressure increments, followed by continuation of ventilation in PCV-VG mode |
| Intervention |
Ventilatory Recruitment Maneuver- Sustained Inflation |
A sustained inflation recruitment maneuver will be applied by increasing airway pressure to a predetermined level and maintaining it for a fixed duration, following institutional protocol, after which ventilation will be continued in PCV-VG mode |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA Physical Status I to III
Patients undergoing laparoscopic surgeries under general anesthesia, including both elective and emergency procedures
Estimated surgery duration greater than 120 minutes |
|
| ExclusionCriteria |
| Details |
Presence of any pre-existing cardiovascular compromise or conditions associated with a fixed cardiac output state (e.g., severe aortic stenosis, restrictive cardiomyopathy)
Presence of any active respiratory symptoms or diagnosed acute respiratory illness at the time of surgery, including conditions such as lower respiratory tract infections, acute bronchospasm, or uncontrolled asthma
Diagnosed neurological disorders or neuromuscular diseases affecting ventilatory mechanics
Clinical or radiological evidence of raised intracranial pressure (ICP)
Known cases of emphysematous bullae, chronic obstructive pulmonary disease (COPD), or pneumothorax 6 Patients with severe diabetes mellitus with autonomic neuropathy or other autonomic nervous system disorders |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To use the ventilatory recruitment maneuvers (VRMs) during Pressure-Controlled Ventilation with Volume Guarantee (PCV-VG) mode inpatients undergoing laparoscopic surgeries under general anesthesia. |
18 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of ventilatory recruitment maneuvers on postoperative pulmonary complications on below mentioned ventilatory and hemodynamic parameters |
18 Months |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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)
|
24/01/2026 |
| 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 prospective randomized controlled study aims to compare two different ventilatory recruitment maneuvers sustained inflation and stepwise incremental in patients undergoing laparoscopic surgery under general anesthesia using PCV VG mode. The study evaluates the effects of these maneuvers on respiratory mechanics oxygenation and hemodynamic parameters. The objective is to determine the more effective and safer recruitment strategy for improving intraoperative ventilation and reducing postoperative pulmonary complications. |