CTRI

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CTRI Number

CTRI/2025/06/088703 [Registered on: 12/06/2025] Trial Registered Prospectively

Last Modified On:

12/10/2025

Post Graduate Thesis

Type of Trial

Observational

Type of Study

Cohort Study

Study Design

Other

Public Title of Study

An international observational study on endotracheal tube removal from the trachea of patients who required ventilator support and recovered from the lung condition called as acute respiratory distress syndrome

Scientific Title of Study

International survey for extubation evaluation and respiratory dynamics in acute respiratory distress syndrome

Trial Acronym

The EXTEND ARDS study

Secondary IDs if Any

Secondary ID	Identifier
NCT06598709	ClinicalTrials.gov

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Mohan Gurjar
Designation	Professor
Affiliation	Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)
Address	Department of Critical Care Medicine Room number 4 Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS) Raebareli Road, Lucknow, India Lucknow UTTAR PRADESH 226014 India
Phone	5222495403
Fax
Email	m.gurjar@rediffmail.com

Details of Contact Person
Scientific Query

Name	Dr Mohan Gurjar
Designation	Professor
Affiliation	Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)
Address	Department of Critical Care Medicine Room number 4 Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS) Raebareli Road, Lucknow, India UTTAR PRADESH 226014 India
Phone	5222495403
Fax
Email	m.gurjar@rediffmail.com

Details of Contact Person
Public Query

Name	Dr Mohan Gurjar
Designation	Professor
Affiliation	Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)
Address	Department of Critical Care Medicine Room number 4 Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS) Raebareli Road, Lucknow, India UTTAR PRADESH 226014 India
Phone	5222495403
Fax
Email	m.gurjar@rediffmail.com

Source of Monetary or Material Support

Japan Agency for Medical Research and Development (Government Agency), 20F, Yomiuri Shimbun Bldg. 1-7-1, Otemachi, Chiyoda-ku, Tokyo. 100-0004, Japan

Primary Sponsor

Name	Japan Agency for Medical Research and Development
Address	20F, Yomiuri Shimbun Bldg. 1-7-1, Otemachi, Chiyoda-ku, Tokyo. 100-0004, Japan
Type of Sponsor	Government funding agency

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

Ethiopia
Greece
India
Italy
Japan
Switzerland
United States of America

Sites of Study

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 23
Name of Committee	Approval Status
AIMS Institutional Ethics Committee	Approved
Biomedical Research, Apollo Hospitals, Visakhapatnam	Approved
Ethics Committee KMH & Group of CIIGMA Hospital	Approved
Father Muller Institutional Ethics Committee	Approved
Fortis Hospital Ethics Committee, Kolkata	Approved
Institutional Ethics Committee (Human) AIIMS	Submittted/Under Review
Institutional Ethics Committee Apollo Multispeciality Hospital, Kolkata	Approved
Institutional Ethics Committee Biomedical and Human Research, IMS & SUM	Approved
Institutional Ethics Committee Biomedical Research Apollo Institute of Medical Sciences and Research, Hyderabad	Approved
Institutional Ethics Committee for Biomedical and Health Research, ELMCH	Approved
Institutional Ethics Committee, AIG	Approved
Institutional Ethics Committee, AIIMS, Bhubaneswar	Approved
Institutional Ethics Committee, IGIMS	Approved
Institutional Ethics Committee, IMS BHU	Approved
Institutional Ethics Committee, IPGMER	Approved
Institutional Ethics Committee, KGMU	Submittted/Under Review
Institutional Ethics Committee, PGIMER, Chandigarh	Approved
Institutional Ethics Committee, SGPGIMS	Approved
Kauvery Hospital Institutional Ethics Committee	Approved
Narayana Health Academic Ethics Committee	Approved
Neotia Getwel Healthcare Centre Ethics Committee	Approved
NIMS Institutional Ethics Committee	Approved
Yashoda Academy of Medical Education and Research	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: J960\|\|Acute respiratory failure,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Nil	Nil
Intervention	Nil	Nil

Inclusion Criteria

Age From	18.00 Year(s)
Age To	90.00 Year(s)
Gender	Both
Details	1. Adult mechanically ventilated patients expected to receive invasive mechanical ventilator for more than 48 hours 2. Patients who meet the diagnosis of ARDS at the start of invasive mechanical ventilation based on a new global definition of ARDS.

ExclusionCriteria

Details

1. Patients who already had tracheostomy at the start of invasive mechanical ventilation
2. Patients who were transferred to participating hospital more than 2 days after the start of invasive mechanical ventilation
3. Patients with terminal conditions at the start of invasive mechanical ventilation
4. Patients who have expressed their refusal to have their clinical data used in research.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
To investigate clinical factor available during spontaneous breathing trial and in the early times after extubation for predicting extubation failure in patients who require ventilator support for acute respiratory distress syndrome (ARDS).	From initiating spontaneous breathing trial to 24 hours after extubation

Secondary Outcome

Outcome	TimePoints
To investigate worldwide epidemiology, management, timing, and outcome for ventilator weaning and extubation in patients who require ventilator support for acute respiratory distress syndrome (ARDS).	At ICU discharge

Target Sample Size

Total Sample Size="1000"
Sample Size from India="150"
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)

02/07/2025

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="3"
Days="0"

Recruitment Status of Trial (Global)

Open to Recruitment

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

Acute respiratory distress syndrome (ARDS) is a life-threatening condition characterized by widespread inflammatory lung injury and most of the time it requires invasive mechanical ventilation. Recent studies reported that the mortality of mechanically ventilated patients with ARDS is still as high as approximately 40%, which implies that better management strategies for them are needed to improve the outcomes. In the management for the mechanical ventilated patients with ARDS, the timing and judgement for extubation is clinically important, because extubation failure can be associated with worse outcome. Considering that the best method to extubate successfully has not been determined, the clinical management at the timing of extubation can be varied by each institution or each country, and we thought that international survey focusing on the management for extubation of ARDS patients would be needed. This international observational study aims to collect the clinical data of mechanically ventilated ARDS patients related with ventilator weaning and extubation internationally as well as the outcome of ARDS patients with extubation failure. This study also aims to identify predictive factors strongly associated with extubation failure in patients who require ventilator support for the ARDS condition.