Evaluating esophageal pressure measurements in ARDS patients during breathing trials
Japanese Esophageal Pressure Sub-study of EXTubation Evaluation and Respiratory Dynamics in Acute Respiratory Distress Syndrome (EXTEND ARDS-J EP Study)
This study is testing if measuring pressure in the esophagus during breathing trials can help doctors predict if patients with ARDS on ventilators can safely be taken off the machine.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Sapporo Medical University Academic / other |
| Locations | 1 site (Sapporo, Hokkaido) |
| Trial ID | NCT06734988 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with Acute Respiratory Distress Syndrome (ARDS) who are mechanically ventilated. It aims to assess whether changes in esophageal pressure (ΔPes) during spontaneous breathing trials can predict the success or failure of extubation. Conducted in Japanese ICUs, the study will utilize standardized Nutrivent balloons to measure esophageal pressure and analyze its correlation with extubation outcomes. The findings could enhance current weaning protocols by providing ARDS-specific data.
Who should consider this trial
Good fit: Ideal candidates are adult mechanically ventilated patients diagnosed with ARDS who are expected to require invasive mechanical ventilation for more than 48 hours.
Not a fit: Patients who have already undergone tracheostomy or have terminal conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve extubation success rates and reduce complications for ARDS patients.
How similar studies have performed: While esophageal pressure monitoring has shown promise in other studies, its specific application in ARDS patients during extubation is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Sapporo, Hokkaido
- Sapporo Medical University — Sapporo, Hokkaido, Japan (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.