Actively Recruiting
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
Eligibility Criteria
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
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
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Trial Site Locations
Total: 1 location
1
Leiden University Medical Center
Leiden, South Holland, Netherlands, 2333ZA
Actively Recruiting
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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