| 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
|
|
|
Primary Sponsor
|
| Name |
AIIMS Mangalagiri |
| Address |
Department of Anesthesiology, IIMS Mangalagiri, Dist- Guntur 522503 |
| Type of Sponsor |
Government 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 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
|
|
|
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. |