Actively Recruiting
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
On this page
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
Sapporo Medical University
Sapporo, Hokkaido, Japan, 060-8556
Actively Recruiting
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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