| CTRI Number |
CTRI/2025/07/091987 [Registered on: 30/07/2025] Trial Registered Prospectively |
| Last Modified On: |
17/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
a study comparing two modes of ventilation in patients undergoing keyhole surgery. |
|
Scientific Title of Study
|
Comparing two modes of ventilation in laproscopic surgeries in Trendelenburg position, Pressure Controlled Ventilation - Volume Guaranteed mode vs Volume Controlled Ventilation mode,
A randomised 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 |
Adithya Sony Raj |
| Designation |
Post graduate |
| Affiliation |
Ballari medical college and research centre, Ballari |
| Address |
Adithya Sony Raj
Department of anaesthesia
cantonment
Ballari medical college and research centre Ballari 33-A, Sree Kumaranillam, Near Heera Garden, Sangeetha Nagar, Pangappara, Opp Pangappara Health Center, Trivandrum, Kerala 695581 Bellary KARNATAKA 583104 India |
| Phone |
8075810169 |
| Fax |
|
| Email |
adithyasonyraj@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Jyothsna M |
| Designation |
Professor |
| Affiliation |
Ballari medical college and research centre, Ballari |
| Address |
Dr Jyothsna M
Department of anesthesia
cantonment
Ballari medical college and research centre Ballari
Bellary KARNATAKA 583104 India |
| Phone |
9900055996 |
| Fax |
|
| Email |
jyothsnabk@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Jyothsna M |
| Designation |
Professor |
| Affiliation |
Ballari medical college and research centre, Ballari |
| Address |
Dr Jyothsna M
Department of anesthesia
cantonment
Ballari medical college and research centre Ballari
Bellary KARNATAKA 583104 India |
| Phone |
9900055996 |
| Fax |
|
| Email |
jyothsnabk@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Ballari medical college and research centre
Ballari
Karnataka
India
583104 |
|
|
Primary Sponsor
|
| Name |
Adithya Sony Raj |
| Address |
Adithya Sony Raj
Department of anaesthesia
cantonment
Ballari medical college and research centre
Ballari
Karnataka
India
583104 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Adithya Sony Raj |
Ballari medical college and research centre |
Department of anesthesia
OT complex
BMCRC
Cantonment
Ballari
Karnataka state Bellary KARNATAKA |
8075810169
adithyasonyraj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Ballari medical college and research centre Ballari |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K35-K38||Diseases of appendix, (2) ICD-10 Condition: K80-K87||Disorders of gallbladder, biliary tract and pancreas, (3) ICD-10 Condition: N80-N98||Noninflammatory disorders of female genital tract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients undergoing elective laparoscopic surgeries in Trendelenburg position.
2. ASA physical status I & II
3. BMI less than or equal to 30 Kg/m2 |
|
| ExclusionCriteria |
| Details |
1. Refusal for the study
2. Any contraindication for general anaesthesia
3. Severe obstructive or restrictive pulmonary disease
4. Suspected difficult intubation
5. Presence of any intracranial pathology |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Peak airway pressure (P peak) after initiation of pneumoperitoneum measured at defined intervals. |
T1- 5 minutes after induction in the supine position and before initiation of the
pneumoperitoneum.
T2- 10 minutes after creation of pneumoperitoneum and achieving a stable peak
pneumoperitoneum level of 12 – 14 mmHg for 5 minutes.
T3- 15 minutes after positioning the patient in Trendelenburg position.
T4- 10 minutes after pneumoperitoneum withdrawal, in the supine position. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Respiratory mechanics like P mean & dynamic compliance in both the groups |
intraoperative |
| Hemodynamic changes (SBP, DBP, MAP & HR) at defined intervals. |
intraoperative |
| Final ventilator settings - Expiratory tidal volume & respiratory rate required to achieve a stable ETCO2 of 35 - 40 mm of Hg. |
intraoperative |
| Incidence of sore throat in both groups & it will be assessed by a four-point categorical pain scale. |
intraoperative |
| ET tube insertion - number of attempts & success rate of insertion in both the groups |
intraoperative |
| Oropharyngeal leak pressure (OLP)measured by closing the expiratory valve of closed circuit at fixed gas flow & noting the equilibrium airway pressure. |
intraoperative |
|
|
Target Sample Size
|
Total Sample Size="70" Sample Size from India="70"
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)
|
11/08/2025 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Laparoscopic surgery often requires the Trendelenburg position, which, along with pneumoperitoneum, increases intra-abdominal pressure and CO2 absorption. This can lead to hypercapnia, acidosis, and impaired ventilation. The upward shift of the diaphragm further reduces pulmonary compliance, functional residual capacity, and worsens ventilation/perfusion mismatch. These challenges call for tailored ventilation strategies to ensure optimal oxygenation and carbon dioxide elimination while minimizing ventilator- induced lung injury. Volume Controlled Ventilation (VCV), Pressure Controlled Ventilation (PCV) and Pressure Controlled Ventilation-Volume Guaranteed (PCV-VG) are three commonly used modes in such settings. VCV delivers a set tidal volume regardless of airway pressures, potentially leading to high peak pressures in patients with reduced compliance. PCV delivers breaths at a preset pressure with decelerating flow decreasing the risk of barotrauma whilst compromising on minute ventilation in non-compliant lungs. On the other hand, PCV-VG is a hybrid mode designed to combine the benefits of both pressure and volume-controlled ventilation, aiming to deliver consistent tidal volume with lower airway pressures by adjusting inspiratory pressure as compliance changes.This study aims to compare VCV and PCV-VG ventilation modes in laparoscopic surgeries under Trendelenburg position, assessing their impact on respiratory mechanics, gas exchange, and pulmonary compliance. The findings could help refine anaesthesia practices, ensuring better perioperative outcomes and minimizing ventilatory complications.Primary objective: To compare peak airway pressures (P peak) in VCV and PCV-VG mode of ventilation in patients undergoing laproscopy surgery in Trendelenburg position. The parameters with respect to respiratory mechanics (mean airway pressure, dynamic compliance) and hemodynamic changes will also be taken into account.
|