| CTRI Number |
CTRI/2024/10/075772 [Registered on: 24/10/2024] Trial Registered Prospectively |
| Last Modified On: |
26/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [PEEP Titration] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Setting of PEEP based on lung ultrasound findings in Acute Respiratory Distress Syndrome |
|
Scientific Title of Study
|
Ultrasound guided titration of Positive End Expiratory Pressure(PEEP) in Acute Respiratory Distress Syndrome(ARDS). |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kairidibo |
| Designation |
Post Doctoral Fellow |
| Affiliation |
Institute of Medical Sciences Banaras Hindu University |
| Address |
Superspeciality Block ICU IMS BHU Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8014784391 |
| Fax |
|
| Email |
Kairidibochewang@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arun RajnPandey |
| Designation |
Associate Professor |
| Affiliation |
Institute of Medical Sciences Banaras Hindu University |
| Address |
Superspeciality Block ICU Department of Anaesthesiology, Critical Care Division
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7704094669 |
| Fax |
|
| Email |
drarunrajpandey@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arun RajnPandey |
| Designation |
Associate Professor |
| Affiliation |
Institute of Medical Sciences Banaras Hindu University |
| Address |
Superspeciality Block ICU Department of Anaesthesiology, Critical Care Division
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7704094669 |
| Fax |
|
| Email |
drarunrajpandey@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Medical Sciences Banaras Hindu University Varanasi 221005 Uttar Pradesh India |
|
|
Primary Sponsor
|
| Name |
Institute of Medical Sciences Banaras Hindu University |
| Address |
Lanka Varanasi Uttar Pradesh 221005 |
| 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 |
| Dr Kairidibo |
Institute of Medical Sciences Banaras Hindu University |
Superspeciality Block ICU Division of Critical Care Medicine Department of Anaesthesiology
Varanasi
UTTAR PRADESH |
8014784391
kairidibochewang@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Banaras Hindu University Institute of Medical Sciences Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J80||Acute respiratory distress syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
PEEP Titration |
In the ARDS patients, based on Lung Ultrasound findings PEEP titration will be done on the mechanically ventilating patients and observed for the change in the lung aeration pattern. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All ARDS patients admitting to ICU
Patients with age 18 years or more
Patients fulfilling Berlin definition to confirm the criteria of ARDS |
|
| ExclusionCriteria |
| Details |
Pregnant patients
P/F ratio less than 150
Driving pressure more than 15cmH2O or plateau pressure more than 30cmH2O
Haemodynamic instability
Barotrauma and organ dysfunction at presentation
Massive blood transfusion
Congestive heart failure or other known heart disease. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine and titrate PEEP in ARDS patients by doing serial lung ultrasound |
0, 12, 24, 36, 48 and 72 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in PF Ratio
Improvement of Chest Radiography
Clinical cure (Weaning from mechanical ventilation). |
6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/11/2024 |
| 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="6"
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
Modification(s)
|
Over the period of 6 months, patients with ARDS on mechanical ventilator will be recruited and serial ultrasound will be done based on which PEEP titration will be done and also look for improvement in PF ratio and chest radiography findings and clinical outcome. |