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)
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1
Leiden University Medical Center
Leiden, South Holland, Netherlands, 2333ZA