Actively Recruiting

Age: 18Years +
All Genders
NCT06584604

Calibration of Esophageal Balloon Catheter in Spontaneous and Mandatory Mechanical Ventilation

Led by Leiden University Medical Center · Updated on 2025-04-22

40

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

Sponsors

L

Leiden University Medical Center

Lead Sponsor

H

Hamilton Medical AG

Collaborating Sponsor

AI-Summary

What this Trial Is About

Calibration of the esophageal balloon catheter (Pes catheter) is important for the right measurement of the esophageal pressure (Pes) and subsequent interpretation of the derived transpulmonary pressures during mechanical ventilation. Both relative changes and absolute values of Pes can be affected by inappropriate filling of the esophageal balloon and by the elastance of the esophagus wall. Therefore one should calibrate the balloon to determine the best filling pressure. Calibration of the Pes catheter has only been validated in mandatory ventilation but not in support modes in which the patient triggers the ventilator and is supported by the mechanical ventilator. Because the forces in the thoracic cage behave differently in comparison with a controlled mode, it is to be expected that the calibration process in a support mode yields different filling volumes in comparison with the calibration process in a controlled mode. This would lead to a more reliable filling volume in support mechanical ventilation and a more reliable derivation of transpulmonary pressure and therefore to a better treatment of patients.

CONDITIONS

Official Title

Calibration of Esophageal Balloon Catheter in Spontaneous and Mandatory Mechanical Ventilation

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years or older
  • Mechanically ventilated in spontaneous mode
  • Sedated with Richmond Agitation Sedation Scale (RASS) between -3 and -5
  • Esophageal balloon catheter (Pes catheter) placed according to protocol
Not Eligible

You will not qualify if you...

  • Medical condition preventing placement of a Pes catheter
  • History of allergic reaction to rocuronium
  • Pregnant
  • Richmond Agitation Sedation Scale (RASS) greater than -3

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Leiden University Medical Center

Leiden, South Holland, Netherlands, 2333ZA

Actively Recruiting

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Research Team

W

Willem Snoep, BSc

CONTACT

A

Abraham Schoe, MD, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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