Actively Recruiting

Age: 16Years +
All Genders
NCT06734988

EXTEND ARDS-J Esophageal Pressure Study

Led by Sapporo Medical University · Updated on 2024-12-16

100

Participants Needed

1

Research Sites

116 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

EXTEND ARDS-J Esophageal Pressure Study

Who Can Participate

Age: 16Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult mechanically ventilated patients aged 16 years or older expected to require invasive mechanical ventilation for more than 48 hours
  • Diagnosed with acute respiratory distress syndrome (ARDS) at the start of invasive mechanical ventilation based on global ARDS definition
Not Eligible

You will not qualify if you...

  • Patients who had a tracheostomy at the start of invasive mechanical ventilation
  • Patients transferred to the participating hospital more than 2 days after starting invasive mechanical ventilation
  • Patients with terminal conditions at the start of invasive mechanical ventilation
  • Patients who have refused to have their clinical data used for research

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Sapporo Medical University

Sapporo, Hokkaido, Japan, 060-8556

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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