EXTEND ARDS-J Esophageal Pressure Study

NCT06734988 | Recruiting

• 1 other identifier: EXTEND_ARDS_J_EP_Study
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Acute respiratory distress syndrome (ARDS) patients require careful assessment before extubation to prevent failure, which is associated with poor outcomes. While current guidelines recommend weaning protocols, these are based on general respiratory failure studies rather than ARDS-specific data. Esophageal pressure (Pes) measurement provides direct assessment of inspiratory effort but is rarely utilized clinically. Objectives: This Japanese sub-study of EXTEND ARDS aims to evaluate whether:

1. 1.ΔPes measurements during spontaneous breathing trials (SBT) can predict SBT failure
2. 2.ΔPes measurements post-extubation can predict 48-hour extubation failure

Conditions

ARDS (Acute Respiratory Distress Syndrome)

Keywords

Esophageal pressure; SBT

Outcome Measures

Primary Outcomes (1)

• Reintubation within 48 hours after extubation

  Occurrence of reintubation events within 48 hours after planned extubation

  48 hours after extubation

Secondary Outcomes (1)

• SBT Failure

  Up to 120 minutes from the start of spontaneous breathing trial

Other Outcomes (1)

• 90 days in-hospital mortality

  From intubation to 90 days after intubation

Study Arms (1)

Mechanically ventilated adult ARDS patients

Adult mechanically ventilated patients (≥ 16 years old) with esophageal pressure monitoring, 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) with esophageal pressure monitoring, 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

• Sapporo Medical University: lead

Study Sites (1)

Sapporo Medical University

Sapporo, Hokkaido, 060-8556, Japan

RECRUITING

MeSH Terms

Conditions

Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 16, 2024
• Study Start: December 4, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

JP (1)