An open label, non-randomized, monocentric, interventional investigation in a cohort of adult critically ill patients
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
30
Gastric motility is recorded continuously with the VIPUN Balloon Catheter for 10 hours.
University Hospitals Leuven
Leuven, Vlaams-Brabant, Belgium
Gastric motility
Assessed with the VIPUN Balloon Catheter
Time frame: 10 hours
gastric emptying rate
Assessed with 13C-octanoate breath test
Time frame: 6 hours
Success rate placement and removal balloon catheter
Success rate completing the procedures to place and remove the balloon catheter
Time frame: Day 0 until day 1 (<24 h)
Safety parameters potentially related to the use of the investigational medical device
Incidence, frequency, severity, seriousness and relatedness of adverse events/effects are recorded.
Time frame: Day 0 until day 30
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