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RECRUITING
NCT06734988

EXTEND ARDS-J Esophageal Pressure Study

Sponsor: Sapporo Medical University

View on ClinicalTrials.gov

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. ΔPes measurements during spontaneous breathing trials (SBT) can predict SBT failure 2. ΔPes measurements post-extubation can predict 48-hour extubation failure Methods: This prospective observational study will be conducted in Japanese ICUs. Esophageal pressure will be measured using standardized Nutrivent balloons (4mL volume) with Hamilton ventilators. Balloon placement in the lower third of the esophagus will be confirmed by cardiac artifacts and chest X-ray. ΔPes will be calculated as the difference between end-expiratory and peak inspiratory esophageal pressure, excluding esophageal contractions. Significance: This study addresses a knowledge gap regarding the utility of esophageal pressure monitoring in ARDS patients during mechanical ventilation weaning. Findings may help optimize extubation timing and improve patient outcomes through objective physiological measurements.

Official title: Japanese Esophageal Pressure Sub-study of EXTubation Evaluation and Respiratory Dynamics in Acute Respiratory Distress Syndrome (EXTEND ARDS-J EP Study)

Key Details

Gender

All

Age Range

16 Years - Any

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2024-12-04

Completion Date

2027-02-28

Last Updated

2024-12-16

Healthy Volunteers

No

Locations (1)

Sapporo Medical University

Sapporo, Hokkaido, Japan