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Calibration of Esophageal Balloon Catheter in Spontaneous and Mandatory Mechanical Ventilation

NCT06584604 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2025-04-22

No results posted yet for this 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.

Conditions

  • Intensive Care Unit
  • Mechanical Ventilation
  • Critical Illness

Interventions

OTHER

There is no intervention

There is no intervention

Sponsors & Collaborators

  • Hamilton Medical AG

    collaborator INDUSTRY

  • Leiden University Medical Center

    lead OTHER

Principal Investigators

  • Abraham Schoe, MD, PhD · Leiden University Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-29
Primary Completion
2026-10-31
Completion
2027-01-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06584604 on ClinicalTrials.gov