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Search / Trial NCT06584604

Calibration of Esophageal Balloon Catheter in Spontaneous and Mandatory Mechanical Ventilation

Launched by LEIDEN UNIVERSITY MEDICAL CENTER · Sep 2, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Esophageal Pressure Esophageal Balloon Catheter Transpulmonary Pressure Mandatory Ventilation Support Ventilation

ClinConnect Summary

This clinical trial is studying how to best calibrate a special tube called an esophageal balloon catheter, which is used to measure pressure in the esophagus of patients who are on mechanical ventilation. The goal is to ensure that when doctors measure this pressure, they get the most accurate results, especially when patients are breathing with some support from a ventilator. This is important because better measurements can help doctors provide better treatment for patients in critical care.

To participate in this trial, you need to be 18 years or older, currently receiving mechanical ventilation in a way that allows you to breathe on your own, and be sedated to a certain level. If you're interested, the study team will explain what you can expect, including the procedures involved and any monitoring that will take place during the trial. It’s important to note that certain medical conditions and a previous allergic reaction to a specific medication might prevent someone from taking part. Overall, this research aims to improve care for patients in intensive care by enhancing the accuracy of pressure measurements during ventilation.

Gender

ALL

Eligibility 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

About Leiden University Medical Center

Leiden University Medical Center (LUMC) is a prominent academic medical center located in the Netherlands, renowned for its commitment to advancing healthcare through innovative research and high-quality patient care. As a clinical trial sponsor, LUMC focuses on translating scientific discoveries into effective therapies, fostering collaborations between researchers, clinicians, and industry partners. The center is dedicated to conducting rigorous clinical studies across various medical fields, ensuring adherence to ethical standards and regulatory requirements while prioritizing patient safety and outcomes. Through its multidisciplinary approach, LUMC aims to contribute significantly to the understanding and treatment of complex health conditions, driving progress in personalized medicine and improving global health.

Locations

Leiden, Zuid Holland, Netherlands

Patients applied

0 patients applied

Trial Officials

Abraham Schoe, MD, PhD

Principal Investigator

Leiden University Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported