Status:

RECRUITING

Calibration of Esophageal Balloon Catheter in Spontaneous and Mandatory Mechanical Ventilation

Lead Sponsor:

Leiden University Medical Center

Collaborating Sponsors:

Hamilton Medical AG

Conditions:

Intensive Care Unit

Mechanical Ventilation

Eligibility:

All Genders

18+ years

Brief 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 pressu...

Detailed Description

In mechanical ventilation the esophageal pressure (Pes) is used to calculate the transpulmonary pressure (PL). The transpulmonary pressure is used to set the positive end expiratory pressure (PEEP) an...

Eligibility Criteria

Inclusion

  • 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

  • Medical condition that excludes the placement of a Pes catheter.
  • Allergic reaction against rocuronium in the past.
  • Pregnant.
  • RASS \> -3

Key Trial Info

Start Date :

December 29 2024

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

January 1 2027

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT06584604

Start Date

December 29 2024

End Date

January 1 2027

Last Update

April 22 2025

Active Locations (1)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

Leiden University Medical Center

Leiden, South Holland, Netherlands, 2333ZA