Calibration of esophageal balloon catheter for patients on mechanical ventilation
Calibration of Esophageal Balloon Catheter in Spontaneous and Mandatory Mechanical Ventilation (PESCA)
This study is testing how to better calibrate a special balloon used in the esophagus to measure pressure in patients on mechanical ventilation, to see if it helps improve their care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Leiden University Medical Center Academic / other |
| Locations | 1 site (Leiden, South Holland) |
| Trial ID | NCT06584604 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on calibrating the esophageal balloon catheter to accurately measure esophageal pressure in patients undergoing spontaneous mechanical ventilation. The calibration process is crucial for determining transpulmonary pressure, which influences ventilator settings and patient care. The study aims to assess how the calibration process differs between mandatory and support ventilation modes, as the dynamics of thoracic forces vary significantly. By ensuring accurate pressure readings, the study seeks to improve patient outcomes in critical care settings.
Who should consider this trial
Good fit: Ideal candidates include mechanically ventilated adults aged 18 and older who are sedated and require support in spontaneous ventilation.
Not a fit: Patients with medical conditions that prevent the placement of a Pes catheter or those who are not sedated may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of ventilator settings, potentially reducing lung damage and improving recovery times for critically ill patients.
How similar studies have performed: Previous studies have validated the calibration of Pes catheters in passive ventilation but this approach in spontaneous ventilation is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years or older. * Mechanically ventilated in spontaneous mode. * Sedated (Richmond Agitation Sedation Scale (RASS) between -3 and -5). * Pes catheter in situ according to the protocol used in the LUMC (Insertion of a Pes catheter is mandatory if it is suspected that te patient will be ventilated for more than 24 hrs.). Exclusion Criteria: * Medical condition that excludes the placement of a Pes catheter. * Allergic reaction against rocuronium in the past. * Pregnant. * RASS \> -3
Where this trial is running
Leiden, South Holland
- Leiden University Medical Center — Leiden, South Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Abraham Schoe, MD, PhD — Leiden University Medical Center
- Study coordinator: Willem Snoep, BSc
- Email: j.w.m.snoep@lumc.nl
- Phone: +31 (0)71-5262164
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.