Clinical Evaluation of the VIPUN Balloon Catheter 0.2 in Critically Ill Patients
NCT ID: NCT03512145
Last Updated: 2019-09-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2018-04-16
2019-08-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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VIPUN Balloon Catheter
Recording of gastric motility with the investigational medical device. Gastric emptying rate of a liquid meal is assessed with the 13C-octanoate breath test.
VIPUN Balloon Catheter
Gastric motility is recorded continuously with the VIPUN Balloon Catheter for 10 hours.
Interventions
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VIPUN Balloon Catheter
Gastric motility is recorded continuously with the VIPUN Balloon Catheter for 10 hours.
Eligibility Criteria
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Inclusion Criteria
* Of adult age (18 years or older)
* ICU patients in which enteral nutrition is planned to be initiated and are expected to stay at least 1 day in ICU on enteral feeding.
* Patients should be mechanically ventilated or have an endotracheal tube or tracheostomy in place.
Exclusion Criteria
* History of gastric or esophageal surgery
* Any gastrointestinal surgery or trauma that could significantly increase the risk related to the investigational medical device in the opinion of the investigator
* Fed by mouth or enterally prior to inclusion
* Patient is moribund
* Known pregnancy or breastfeeding women
* Receives gastroprokinetic medication (e.g., erythromycin, metoclopramide, domperidone)
18 Years
ALL
No
Sponsors
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Prof Dr Jan Tack
OTHER
Responsible Party
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Prof Dr Jan Tack
Member of staff hepato-gastroenterology
Locations
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University Hospitals Leuven
Leuven, Vlaams-Brabant, Belgium
Countries
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Other Identifiers
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S61147
Identifier Type: -
Identifier Source: org_study_id
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