| CTRI Number |
CTRI/2025/12/099671 [Registered on: 22/12/2025] Trial Registered Prospectively |
| Last Modified On: |
22/12/2025 |
| 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
|
Comparison of driving pressure guided ventilation versus standard ventilatory strategy on post operative lung collapse in patients undergoing liver transplant |
|
Scientific Title of Study
|
Comparison of Driving pressure guided
ventilation versus conventional ventilation on postoperative lung atelectasis in patients
undergoing Living donor liver transplant (LDLT)- A single centre 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 |
Pragya Maheshwari |
| Designation |
Senior Resident |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Department of Anaesthesia, Institute of Liver and Biliary Sciences, D1, Vasant Kunj, Delhi
South
DELHI
110070
India |
| Phone |
7838643123 |
| Fax |
|
| Email |
pragyamaheshwari19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anil Yadav |
| Designation |
Assistant Professor |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Department of Anaesthesia, Institute of Liver and Biliary Sciences, D1, Vasant Kunj, Delhi
South
DELHI
110070
India |
| Phone |
8089337600 |
| Fax |
|
| Email |
doc.anilyadav@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anil Yadav |
| Designation |
Assistant Professor |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Department of Anaesthesia, Institute of Liver and Biliary Sciences, D1, Vasant Kunj, Delhi
DELHI
110070
India |
| Phone |
8089337600 |
| Fax |
|
| Email |
doc.anilyadav@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Institute of Liver and Biliary Sciences |
| Address |
D1, Vasant Kunj, Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Pragya Maheshwari |
Institute of Liver and Biliary Sciences |
HPB OT complex, 3rd and 4th floor, Institute of Liver and biliary Sciences, Delhi
South
DELHI |
7838643123
pragyamaheshwari19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee / Institutional Review Board ILBS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K703||Alcoholic cirrhosis of liver, (2) ICD-10 Condition: K739||Chronic hepatitis, unspecified, (3) ICD-10 Condition: O||Medical and Surgical, (4) ICD-10 Condition: K746||Other and unspecified cirrhosis ofliver, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Driving pressure guided ventilation |
The PEEP would be titrated at multiple time points intraoperatively based on the driving pressure |
| Comparator Agent |
Standard lung protective ventilation |
Standard lung protective ventilation with a fixed PEEP 5 would be used throughout the intraoperative period |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients aged 18-60 years undergoing Living Donor Liver Transplant |
|
| ExclusionCriteria |
| Details |
Preexisting severe pulmonary disease, severe hepatopulmonary syndrome, severe hydrothorax, cardiac dysfunction such as valvular abnormalities, severe systolic dysfunction, acute liver failure, retransplantation, BMI more than 40, patients with chest wall deformity or history of previous thoracic surgeries, patient refusal. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The incidence of postoperative pulmonary complications. |
Upto post operative day 3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
05/01/2026 |
| 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="0"
Months="8"
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 single-centre randomized controlled trial evaluates whether driving pressure-guided ventilation offers better postoperative pulmonary outcomes than conventional lung-protective ventilation in adult patients undergoing living donor liver transplantation. The liver transplant patients often experience unique respiratory challenges, including decreased lung compliance due to factors like ascites and hepatopulmonary syndrome. These patients are at an increased risk for postoperative pulmonary complications (PPCs), making optimal ventilatory management a clinical priority.
Research shows that driving pressure, a measurement reflecting the pressure used to deliver each breath, is a stronger predictor of PPCs than conventional ventilator parameters. Although numerous studies in non-transplant surgical populations support limiting driving pressure to reduce the risk of PPCs, no randomized trials have specifically addressed this strategy in the context of liver transplantation. Unique characteristics of liver transplant recipients, such as altered physiology, dynamic intraoperative changes, and specific concerns around hemodynamic stability, make it necessary to validate these findings within the transplant cohort.
The proposed study fills this gap by directly comparing the incidence of lung atelectasis (as measured by lung ultrasound), oxygenation indices, pulmonary complications, respiratory and hemodynamic parameters, ventilator duration, ICU stay length, and early graft outcomes between the two ventilatory strategies. |