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EXTEND ARDS-J Esophageal Pressure Study

NCT06734988 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2024-12-16

No results posted yet for this study

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.

Conditions

  • ARDS (Acute Respiratory Distress Syndrome)

Sponsors & Collaborators

  • Sapporo Medical University

    lead OTHER

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-04
Primary Completion
2026-12-31
Completion
2027-02-28

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06734988 on ClinicalTrials.gov