RecruitingNCT06734988

EXTEND ARDS-J Esophageal Pressure Study

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

Sponsor

Sapporo Medical University

Enrollment

100 participants

Start Date

Dec 4, 2024

Study Type

OBSERVATIONAL

Conditions

ARDS (Acute Respiratory Distress Syndrome)

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.

Eligibility

Min Age: 16 Years

Inclusion Criteria2

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.

Exclusion Criteria4

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

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