| CTRI Number |
CTRI/2025/02/080692 [Registered on: 17/02/2025] Trial Registered Prospectively |
| Last Modified On: |
14/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare if pressure required to keep lung units open which is set using EIT is not inferior to the standard method |
|
Scientific Title of Study
|
A Non Inferiority Trial of EIT Guided PEEP Optimization Versus ARDSnet Low PEEP Protocol in ARDS Patients OPT PEEP trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rahul |
| Designation |
DrNB Resident |
| Affiliation |
Medanta The Medicity |
| Address |
Medanta Institute of Critical Care and Anesthesia, ICU 9, ICU 10, ICU 11, ICU 12, 2nd Floor, Medanta The Medicity, Sector 38, Gurgaon, Haryana, India
Medanta Institute of Critical Care and Anesthesia, ICU 9, ICU 10, ICU 11, ICU 12, 2nd Floor, Medanta The Medicity, Sector 38, Gurgaon, Haryana, India
Gurgaon
HARYANA
122001
India |
| Phone |
8901000102 |
| Fax |
|
| Email |
rggoyat@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rahul |
| Designation |
DrNB Resident |
| Affiliation |
Medanta The Medicity |
| Address |
Medanta Institute of Critical Care and Anesthesia, ICU 9, ICU 10, ICU 11, ICU 12, 2nd Floor, Medanta The Medicity, Sector 38, Gurgaon, Haryana, India
Medanta Institute of Critical Care and Anesthesia, ICU 9, ICU 10, ICU 11, ICU 12, 2nd Floor, Medanta The Medicity, Sector 38, Gurgaon, Haryana, India
Gurgaon
HARYANA
122001
India |
| Phone |
8901000102 |
| Fax |
|
| Email |
rggoyat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anant Vikram Pachisia |
| Designation |
Consultant |
| Affiliation |
Medanta The Medicity |
| Address |
Medanta Institute of Critical Care and Anesthesia, ICU 9, ICU 10, ICU 11, ICU 12, 2nd Floor, Medanta The Medicity, Sector 38, Gurgaon, Haryana, India
Gurgaon
HARYANA
122001
India |
| Phone |
9810368132 |
| Fax |
|
| Email |
anantndin@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of critical care and anesthesiology Medanta The Medicity sector 38 Gurgaon Haryana 122001 India |
|
|
Primary Sponsor
|
| Name |
Dr Rahul |
| Address |
Institute of Critical Care and Anaesthesiology Medanta The Medicity Gurgaon 122001 |
| Type of Sponsor |
Other [Self] |
|
|
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 Rahul |
Medanta the Medicity |
ICU 9 ICU 10 ICU 11 ICU 12 2nd floor Institute of critical care and Anesthesia Medanta The Medicity Sector 38 Gurgaon Haryana 122001
Gurgaon
HARYANA |
8901000102
rggoyat@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medanta Institutional Ethics Committee (MIEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J189||Pneumonia, unspecified organism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ARDSnet low PEEP table |
ARDSnet low PEEP table is used routinely to set a PEEP in ARDS patient |
| Intervention |
Electric Impedance Tomography guided PEEP titration |
EIT is a non invasive method for assessing lung for ventilation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
Patients age above 18 years
Diagnosed with ARDS according to the Berlin Definition
Intubated and mechanically ventilated
|
|
| ExclusionCriteria |
| Details |
Pregnancy
EIT contraindications example pacemaker or automatic implantable cardioverter defibrillator
Severe intracranial hypertension
Pneumothorax pneumomediastinum subcutaneous emphysema or high risk of pneumothorax
Refractory hypotension as assessed by attending physician
End stage lung disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| PaO2 and FiO2 ratio |
0 6 12 18 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Driving pressure
Mechanical power |
0 6 12 18 24 hours |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
27/02/2025 |
| 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) |
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
|
PEEP titration guided by Electrical Impedance Tomography (EIT) is non-inferior to PEEP determined by the ARDSnet low PEEP table in guided PEEP titration improving oxygenation and other parameters, such as the P/F ratio, driving pressure, and mechanical power, in patients with ARDS. Primary objective is to compare whether PEEP titration guided by Electrical Impedance Tomography (EIT) is non-inferior to PEEP derived from the ARDSnet low PEEP table in improving oxygenation, as measured by the P/F ratio, in patients with ARDS. Secondary objective is to compare the impact of PEEP as guided by EIT versus ARDSnet low PEEP table on driving pressure. To assess the impact of PEEP as guided by EIT versus ARDSnet low PEEP table on mechanical power. This is a prospective, randomized, controlled, single-center, non-inferiority trial designed to compare the efficacy and safety of an Electrical Impedance Tomography (EIT)-guided PEEP titration strategy versus the ARDSNet low PEEP/FiO2 table for optimizing mechanical ventilation in patients with ARDS. Patients diagnosed with ARDS who requires mechanical ventilation or already mechanically ventilated with ARDS diagnosis. Inclusion criteria for study are Patients age >18 years.Diagnosed with ARDS according to the Berlin Definition.Intubated and mechanically ventilated.Exclusion Criteria are Pregnancy.EIT contraindications (e.g., pacemaker or automatic implantable cardioverter defibrillator).Severe intracranial hypertension.Pneumothorax, pneumomediastinum, subcutaneous emphysema, or high risk of pneumothorax.Refractory hypotension as assessed by attending physician. |