EXTEND ARDS-J Esophageal Pressure Study

NCT06734988 · tracked via the Priya Life Science Japan tracker

Sponsor

Sapporo Medical University

Phase

Observational

Started

2024-12-04

Last updated

2024-12-16

Condition(s) studied

ARDS (Acute Respiratory Distress Syndrome)

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.

Eligibility

Sex

ALL

Min age

16 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Adult mechanically ventilated patients (≥ 16 years old) with esophageal pressure monitoring, expected to receive invasive mechanical ventilator for more than 48 hours 2. Patients who meet the diagnosis of ARDS at the start of invasive mechanical ventilation based on a new global definition of ARDS. Exclusion Criteria: 1. Patients who already had tracheostomy at the start of invasive mechanical ventilation 2. Patients who were transferred to participating hospital more than 2 days after the start of invasive mechanical ventilation 3. Patients with terminal conditions at the start of invasive mechanical ventilation 4. Patients who have expressed their refusal to have their clinical data used in research

Primary outcome measure(s)

Reintubation within 48 hours after extubation — 48 hours after extubation
Occurrence of reintubation events within 48 hours after planned extubation

Trial sites (1)

Facility	City	Region	Status
Sapporo Medical University	Sapporo	Hokkaido	Recruiting

Other trials for the same condition

International Survey for EXTubation Evaluation and Respiratory Dynamics in Acute Respiratory Distress Syndrome Enrolling by invitation

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06734988 on ClinicalTrials.gov ↗ ← All trials in Japan