NCT03512145CompletedNot Applicable
A Prospective Evaluation of the VIPUN Balloon Catheter 0.2: an Investigational Medical Device for the Monitoring of Gastric Motility in Adult Critically Ill Patients
Prof Dr Jan Tack1 site in 1 country30 target enrollmentStarted: April 16, 2018Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Gastric motility
Study Overview
Brief Summary
An open label, non-randomized, monocentric, interventional investigation in a cohort of adult critically ill patients
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Signed Informed Consent
- •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
- •Contra-indication for (re-) placement of nasogastric feeding catheters.
- •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)
Arms & Interventions
VIPUN Balloon Catheter
Experimental
Recording of gastric motility with the investigational medical device. Gastric emptying rate of a liquid meal is assessed with the 13C-octanoate breath test.
Intervention: VIPUN Balloon Catheter (Device)
Outcomes
Primary Outcomes
Gastric motility
Time Frame: 10 hours
Assessed with the VIPUN Balloon Catheter
gastric emptying rate
Time Frame: 6 hours
Assessed with 13C-octanoate breath test
Secondary Outcomes
- Safety parameters potentially related to the use of the investigational medical device(Day 0 until day 30)
- Success rate placement and removal balloon catheter(Day 0 until day 1 (<24 h))
Investigators
Prof Dr Jan Tack
Member of staff hepato-gastroenterology
Universitaire Ziekenhuizen KU Leuven
Study Sites (1)
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