| CTRI Number |
CTRI/2025/07/091554 [Registered on: 23/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
Type of Study
Modification(s)
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
To decrease mortality rate of adults patients admitted in a ICU with acute respiratory failure by minimising ventilation induced lung injury. |
|
Scientific Title of Study
|
TO EVALUATE EFFECT OF MECHANICAL POWER DIRECTED LUNG PROTECTIVE VENTILATION STRATEGY ON TREATMENT OUTCOME IN PATIENTS WITH ACUTE RESPIRATORY FAILURE- A PROSPECTIVE 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 |
SRIPARNA MANDAL |
| Designation |
DRNB CRITICAL CARE MEDICINE 1st YEAR |
| Affiliation |
FORTIS ESCORTS HEART INSTITUTE, DEPARTMENT OF CRITICAL CARE MEDICINE, DELHI |
| Address |
DEPARTMENT OF CRTICAL CARE MEDICINE, GROUND FLOOR ICU,FORTIS ESCORTS HEART INSTITUTE, DELHI
New Delhi
DELHI
110025
India |
| Phone |
9609560345 |
| Fax |
|
| Email |
sriparna.mandal19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PUSHPA PRIYADARSHANI |
| Designation |
SENIOR CONSULTANT |
| Affiliation |
FORTIS ESCORTS HEART INSTITUTE, DEPARTMENT OF CRITICAL CARE MEDICINE, DELHI |
| Address |
DEPARTMENT OF CRITICAL CARE MEDICINE, GROUND FLOOR ICU, FORTIS ESCORTS HEART INSTITUTE, DELHI
New Delhi
DELHI
110025
India |
| Phone |
8130041896 |
| Fax |
|
| Email |
drpushpa23@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PUSHPA PRIYADARSHANI |
| Designation |
SENIOR CONSULTANT |
| Affiliation |
FORTIS ESCORT HEART INSTITUTE |
| Address |
DEPARTMENT OF CRITICAL CARE MEDICINE, GROUND FLOOR ICU ,FORTIS ESCORTS HEART INSTITUTE,DELHI
South
DELHI
110076
India |
| Phone |
8130041896 |
| Fax |
|
| Email |
drpushpa23@gmail.com |
|
|
Source of Monetary or Material Support
|
| FORTIS ESCORTS HEART INSTITUTE,OKHLA,NEW DELHI-110025 |
|
|
Primary Sponsor
|
| Name |
FORTIS ESCORTS HEART INSTITUTE |
| Address |
FORTIS ESCORTS HEART INSTITUTE OKHLA DELHI-110025 |
| 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 SRIPARNA |
FORTIS ESCORTS HEART INSTITUTE |
CRITICAL CARE MEDICINE DEPARTMENT, GROUND FLOOR, ICU-1
South
DELHI |
9609560345
sriparna.mandal19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE FEHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00-J99||Diseases of the respiratory system, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Acute respiratory failure (ARF), defined as the ratio of partial pressure of oxygen (PaO2) to fraction of inspired oxygen (FiO2) less than 300 mmHg on admission, who will receive invasive mechanical ventilation for more than 48 hrs. |
|
| ExclusionCriteria |
| Details |
1. Received treatment with extracorporeal
life support;
2. Age less than 18 years; or
3. Mechanical power ≤ 10 J/min on admission (with a possible lower risk of lung injury)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mortality |
baseline,4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mechanical power |
baseline, after 24 hours |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/08/2025 |
| 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="6"
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
|
Mechanical ventilation is potentially life saving therapy for patients with acute respiratory failure. But unfortunately this invasive procedure has induced further lung injury- termed as ventilator induced lung injury (VILI). Thus it has become imperative that ventilator parameters should be adjusted to optimize gas exchange and with an attempt to minimize injury.The amount of energy per unit time, expressed as joules/minute is ,referred as mechanical power. |