Evaluating esophageal pressure measurements in ARDS patients during breathing trials
Official title: Japanese Esophageal Pressure Sub-study of EXTubation Evaluation and Respiratory Dynamics in Acute Respiratory Distress Syndrome (EXTEND ARDS-J EP Study)
Run by Sapporo Medical University · NCT06734988 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 16 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Sapporo Medical University Academic / other |
| Locations | 1 site (Sapporo, Hokkaido) |
| Status | Recruiting |
| Started | December 4, 2024 |
| Main results expected | December 31, 2026 |
| Study ends | February 28, 2027 |
| Registry record updated | December 16, 2024 |
| Trial ID | NCT06734988 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients who have already undergone tracheostomy or have terminal conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
Why it matters
Potential benefit: If successful, this study could improve extubation success rates and reduce complications for ARDS patients.
How similar studies have gone: While esophageal pressure monitoring has shown promise in other studies, its specific application in ARDS patients during extubation is relatively novel.
Who can join: the full rules
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 it's running
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Sapporo Medical University
Sapporo, Hokkaido, Japan Recruiting
Similar studies
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This pilot study tests two personalized PEEP strategies in adults with ARDS to see which approach better supports breathing mechanics by using a recruitment potential measure.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.