Clinical Trials in the Netherlands / NCT06584604
Recruiting Observational

Calibration of Esophageal Balloon Catheter in Spontaneous and Mandatory Mechanical Ventilation

NCT06584604 · tracked via the Priya Life Science Netherlands tracker
Phase
Observational
Started
2024-12-29
Last updated
2025-04-22

Condition(s) studied

Intensive Care UnitMechanical VentilationCritical Illness

Investigational drug(s) / intervention(s)

There is no intervention

There is no intervention: There is no intervention

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Leiden University Medical Center Leiden South Holland Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06584604 on ClinicalTrials.gov ↗ ← All trials in the Netherlands