| CTRI Number |
CTRI/2025/11/097832 [Registered on: 21/11/2025] Trial Registered Prospectively |
| Last Modified On: |
21/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Perioperative Pulmonary morbidity in patients ventilated with driving pressure guided ventilation and protective lung ventilation strategy. |
|
Scientific Title of Study
|
Perioperative pulmonary morbidity following one lung anaesthesia using driving pressure guided ventilation and protective lung ventilation strategy: A Prospective comparative Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aditi Chaturvedi |
| Designation |
DNB Resident |
| Affiliation |
Medanta, The Medicity |
| Address |
Department of Anesthesiology and Critical Care, Medanta, The Medicity
Gurgaon
HARYANA
122003
India |
| Phone |
8447509440 |
| Fax |
|
| Email |
aditic95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sangeeta Khanna |
| Designation |
Head of department, department of Anesthesiology |
| Affiliation |
Medanta, The Medicity |
| Address |
Department of Anesthesiology, Medanta The Medicity
Gurgaon
HARYANA
122003
India |
| Phone |
9818604447 |
| Fax |
|
| Email |
sangeeta.khanna@medanta.org |
|
Details of Contact Person
Public Query
|
| Name |
Aditi Chaturvedi |
| Designation |
DNB Resident |
| Affiliation |
Medanta, The Medicity |
| Address |
Department of Anesthesiology, Medanta The Medicity
Gurgaon
HARYANA
122003
India |
| Phone |
8447509440 |
| Fax |
|
| Email |
aditic95@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Medanta, The Medicity |
| Address |
Medanta, The Medicity, Sector 39, Gurugram |
| 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 |
| Aditi Chaturvedi |
Medanta, The Medicity |
Department of Anesthesiology Medanta, The Medicity, sector 39 , Gurugram
Gurgaon
HARYANA |
8447509440
aditic95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medanta Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J984||Other disorders of lung, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1&2
Localised lung pathology
|
|
| ExclusionCriteria |
| Details |
Non consenting patients
Pre existing diffuse lung disease
Patients with CNS pathology, renal dysfunction, myasthenia gravis
Patients with poor cardiac function |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Intra operative lung compliance |
T1- two lung ventilation
T2- initiation of one lung ventilation
T3- re-initiation of two lung ventilation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post operative pulmonary complications |
POD 1,3,5,7 |
| Incidence of ALI by Berlin criteria within POD7 |
POD7 |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
02/12/2025 |
| 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="0"
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
|
Anaesthesia premedication and induction, intra operative monitoring would be standard in both the groups. In driving pressure guided ventilation, manoeuvre for lowering driving pressure which consist of alveolar recruitment manoeuvre to open collapsed alveoli and an individualised PEEP titration to achieve lowest Driving pressure would be performed. In protective lung ventilation group, similar recruitment manoeuvre will be performed by compressing the reservoir bag and subsequently fixed PEEP will be applied. Intra operative lung compliance and post op pulmonary complications will be noted. |