International Survey for EXTubation Evaluation and Respiratory Dynamics in Acute Respiratory Distress Syndrome

NCT06598709 | Enrolling By Invitation DMC

• 1 other identifier: EXTEND_ARDS_study
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

EXTEND ARDS study is an international survey for ventilator weaning and extubation among ARDS patients. This study will be conducted on behalf of the Japanese ARDS Clinical Practice Guideline 2024 Committee as well as endorsement of the Japanese Society of Intensive Care Medicine, the Japanese Respiratory Society, and the Japanese Society of Respiratory Care Medicine. This survey aims to prospectively 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. The contents of mechanical ventilation settings, respiratory conditions, and blood examination data will be collected.

Conditions

ARDS (Acute Respiratory Distress Syndrome)

Keywords

extubation; ARDS; SBT; Spontaneous Breathing Trial; Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (2)

• 90 days in-hospital mortality

  90 days in-hospital mortality

  From intubation to 90 days after intubation

• occurrence of re-intubation event

  occurrence of re-intubation event

  From extubation until the hospital discharge, assessed up to 24 months

Study Arms (1)

Mechanically ventilated adult ARDS patients

Adult mechanically ventilated patients (≥ 16 years old) expected to receive invasive mechanical ventilator for more than 48 hours

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult mechanically ventilated patients (≥ 16 years old) expected to receive invasive mechanical ventilator for more than 48 hours

You may qualify if:

• Adult mechanically ventilated patients (≥ 16 years old) expected to receive invasive mechanical ventilator for more than 48 hours
• Patients who meet the diagnosis of ARDS at the start of invasive mechanical ventilation based on a new global definition of ARDS.

You may not qualify if:

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

Sponsors & Collaborators

• Hiroshima University: lead

Study Sites (1)

Hiroshima university hospital

Hiroshima, Japan

Location

MeSH Terms

Conditions

Acute Lung Injury; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Department of Emergency and Critical Care Medicine, Graduate School of Biomedical and Health Sciences, Hiroshima University

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: September 19, 2024
• Study Start: November 1, 2024
• Primary Completion: October 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

JP (1)