| CTRI Number |
CTRI/2022/08/044880 [Registered on: 24/08/2022] Trial Registered Prospectively |
| Last Modified On: |
18/10/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Management practices for low oxygen saturations in Indian ICUs |
|
Scientific Title of Study
|
Profile of subjects with acute hypoxaemic
respiratory failure in adult
Indian population: Multi-centre study
(Indian ARDSnet group) |
| Trial Acronym |
ARDS-I |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SUBHAL DIXIT |
| Designation |
Consultant Critical Care |
| Affiliation |
Sanjeevan Hospital |
| Address |
Sanjeevan Hospital
F P23 OFF KARVE ROAD
KASHIBHAI KHILARE PATH
OPP PUNE CENTRAL
PUNE
Pune
MAHARASHTRA
411004
India |
| Phone |
9822050240 |
| Fax |
|
| Email |
subhaldixit@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Srinivas Samavedam |
| Designation |
Consultant Critical Care |
| Affiliation |
Virinchi Hospital Hyderabad |
| Address |
Virinchi Hospital
Road no 1 Banjara Hills
Hyderabad
Virinchi Hospital
Road no 1 Banjara Hills
Hyderabad
Hyderabad
TELANGANA
500034
India |
| Phone |
9866343632 |
| Fax |
|
| Email |
srinivas3271@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Inderpal Singh Sehgal |
| Designation |
Assistant Professor |
| Affiliation |
PGI Chandigarh |
| Address |
Department of Pulmonary Medicine
PGIMER
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8437610088 |
| Fax |
|
| Email |
inderpgi@outlook.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Indian Society of Critical Care Medicine |
| Address |
Unit 13 and 14 First Floor
Hind Service Industries Premises Cooperative Society
Near Chaitya Bhoomi
Off Veer Savarkar Marg
Dadar
Mumbai 400028
Maharashtra |
| Type of Sponsor |
Other [Charitable Society] |
|
|
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 |
| Srinivas Samavedam |
Virinchi Hospital |
Department of Critical Care
3 FLOOR
ROOM NO 301
Road no 1
Banjara Hills
Hyderabad
Hyderabad
TELANGANA |
9866343632
srinivas3271@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| Apollo Hospitals |
Approved |
| Ethics Committee Sanjeevan Hospital |
Approved |
| FortisNoida |
Approved |
| Institutional Ethics Committee Care Hospitals, Banjara Hills |
Approved |
| Institutional Ethics Committee Medicover Hospitals |
Approved |
| InstitutionalEthicsCommitteeFortisHospitalNoida |
Approved |
| PGIMER Chandigrah IEC |
Approved |
| Poona Medical Research Foundation |
Approved |
| The Medanta Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J96||Respiratory failure, not elsewhereclassified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients with Acute Hypoxemic Respiratory Failure |
|
| ExclusionCriteria |
| Details |
Non consenting patients |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
ICU length of stay
Hospital Length of stay
Ventilator days |
90 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mortality |
28 days |
|
|
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)
|
01/09/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/09/2022 |
| 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)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
Data collection in progress |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Acute Hypoxemic Respiratory Failure is a medical emergency needing ICU admission. Several approaches are available to manage this condition. Practices across the country are heterogenous. This study aims to capture the practices in an attempt to develop a standard recommendation |