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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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