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CTRI Number  CTRI/2026/01/100463 [Registered on: 07/01/2026] Trial Registered Prospectively
Last Modified On: 07/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   comparison of lung ventilation with different pressure levels in laparoscopic surgery 
Scientific Title of Study   Comparative assessment of electrical impedance tomography guided regional ventilation with different levels of PEEP in laparoscopic cholecystectomy: A Randomised Control 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  Samarjit Dey 
Designation  Additional Professor 
Affiliation  AIIMS Mangalagiri 
Address  Department of Anaesthesiology, AIIMS, Mangalagiri
Mid valley city Mangalagiri
Guntur
ANDHRA PRADESH
522503
India 
Phone  7805920791  
Fax    
Email  drsamarjit@aiimsmangalagiri.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Samarjit Dey 
Designation  Additional Professor 
Affiliation  AIIMS Mangalagiri 
Address  Department of Anaesthesiology, AIIMS, Mangalagiri

Guntur
ANDHRA PRADESH
522503
India 
Phone  7805920791  
Fax    
Email  drsamarjit@aiimsmangalagiri.edu.in  
 
Details of Contact Person
Public Query
 
Name  Samarjit Dey 
Designation  Additional Professor 
Affiliation  AIIMS Mangalagiri 
Address  Department of Anaesthesiology, AIIMS, Mangalagiri

Guntur
ANDHRA PRADESH
522503
India 
Phone  7805920791  
Fax    
Email  drsamarjit@aiimsmangalagiri.edu.in  
 
Source of Monetary or Material Support  
AIIMS Mangalagiri 
 
Primary Sponsor  
Name  AIIMS Mangalagiri 
Address  Department of Anesthesiology, IIMS Mangalagiri, Dist- Guntur 522503 
Type of Sponsor  Government medical college 
 
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 Samarjit Dey  AIIMS Mangalagiri  OT complex, First floor, IPD Block, AIIMS Mangalagiri
Guntur
ANDHRA PRADESH 
7805920791

drsamar0002@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
All India Instititute of medical science mangalagiri institute ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group P10 = PEEP 10 cmH2O  Patients will be ventilated with a tidal volume (Vt) of 6–8 mL/kg PBW with FiO2 0.4–0.5 and minute ventilation will be titrated to achieve the end-tidal carbon dioxide concentration between 35 and 40 mmHg. Designated PEEP will be set according to the group allocation– either PEEP 5 cms of H2O or 10 cms of H2O. 
Comparator Agent  Group P5 = PEEP 5 cmH2O  Patients will be ventilated with a tidal volume (Vt) of 6–8 mL/kg PBW with FiO2 0.4–0.5 and minute ventilation will be titrated to achieve the end-tidal carbon dioxide concentration between 35 and 40 mmHg. Designated PEEP will be set according to the group allocation– either PEEP 5 cms of H2O or 10 cms of H2O. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Age- 18-65 years
Both genders
American society of anaesthesiologist (ASA) physical status I-II
Posted for routine lap cholecystectomy
 
 
ExclusionCriteria 
Details  Patient refusal
Cardiopulmonary diseases
Pregnancy & lactating mothers
Conversion into open cholecystectomy due to any reason
Gross anatomical deformities of the chest
• Patients with chronic obstructive pulmonary disease
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Change in the regional distribution of tidal variation (TV ROI %)
2. Regional change of end expiratory lung impedance (EELI - % win /% loss)
 
1. Change in the regional distribution of tidal variation (TV ROI %)
2. Regional change of end expiratory lung impedance (EELI - % win /% loss)
 
 
Secondary Outcome  
Outcome  TimePoints 
1. Number of patients requiring oxygen supplementation in the postoperative period  Regional lung ventilation, collapse and overdistension will be monitored by using Drager Pulmovista 500 (model, country name) at pre induction (T0), induction (T1), during abdominal CO2 insufflation(T2) , at the end of the surgery(T3) and in the post operative period at 15 minutes(T4),30 minutes(T5) and 1 hour(T6). Recruitment will be given based on the regional ventilation, collapse and overdistension as seen on EIT monitor .RAMP technique will be used for recruitment that is progressive increase in airway pressure up to 40 cm H2O reached at 40 seconds after the onset of inflation. 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   19/01/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  19/01/2026 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
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 study investigates how different levels of positive end-expiratory pressure (PEEP) impact lung ventilation during laparoscopic cholecystectomy. General anaesthesia during surgery can lead to complications like atelectasis (lung collapse) and reduced oxygen levels, particularly in the lower lung regions. This is worsened by the pressure from the abdominal insufflation used in laparoscopic procedures.

To manage this, PEEP is often used to keep the lungs inflated, but too much pressure can also cause overdistension, which might be harmful. The study aims to explore how two different PEEP levels (5 cm H2O and 10 cm H2O) affect lung ventilation and oxygenation, using a technique called electrical impedance tomography (EIT), which provides real-time images of lung activity.

The study’s primary goal is to compare how these two PEEP levels impact lung regions, specifically looking at lung collapse and overdistension at different stages of surgery. Secondary goals include analyzing the relationship between ventilation and other ventilatory parameters, assessing the role of EIT in guiding lung recruitment maneuvers, and determining how oxygen supplementation needs change post-surgery.

Conducted at AIIMS Mangalagiri, this is a randomized controlled study involving patients undergoing elective laparoscopic cholecystectomy. It will monitor ventilation using the Drager Pulmovista 500 EIT system and compare oxygenation and lung mechanics during different phases of the surgery.

This research could provide valuable insights into how to optimize PEEP settings during laparoscopic surgery, reducing risks of lung complications and improving patient outcomes.

 
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