Back to resultsClinical Evaluation of the VIPUN Balloon Catheter 0.2 in Critically Ill Patients (ANTERO-2)
Primary Purpose
Critical Illness, Intolerance; Nutritional, Delayed Gastric Emptying
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
VIPUN Balloon Catheter
Sponsored by
About this trial
This is an interventional diagnostic trial for Critical Illness
Eligibility Criteria
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)
Sites / Locations
- University Hospitals Leuven
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
VIPUN Balloon Catheter
Arm Description
Recording of gastric motility with the investigational medical device. Gastric emptying rate of a liquid meal is assessed with the 13C-octanoate breath test.
Outcomes
Primary Outcome Measures
Gastric motility
Assessed with the VIPUN Balloon Catheter
gastric emptying rate
Assessed with 13C-octanoate breath test
Secondary Outcome Measures
Success rate placement and removal balloon catheter
Success rate completing the procedures to place and remove the balloon catheter
Safety parameters potentially related to the use of the investigational medical device
Incidence, frequency, severity, seriousness and relatedness of adverse events/effects are recorded.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03512145
Brief Title
Clinical Evaluation of the VIPUN Balloon Catheter 0.2 in Critically Ill Patients
Acronym
ANTERO-2
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
April 16, 2018 (Actual)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
August 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prof Dr Jan Tack
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
An open label, non-randomized, monocentric, interventional investigation in a cohort of adult critically ill patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Intolerance; Nutritional, Delayed Gastric Emptying, Gastric Motor Dysfunction
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VIPUN Balloon Catheter
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
VIPUN Balloon Catheter
Intervention Description
Gastric motility is recorded continuously with the VIPUN Balloon Catheter for 10 hours.
Primary Outcome Measure Information:
Title
Gastric motility
Description
Assessed with the VIPUN Balloon Catheter
Time Frame
10 hours
Title
gastric emptying rate
Description
Assessed with 13C-octanoate breath test
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Success rate placement and removal balloon catheter
Description
Success rate completing the procedures to place and remove the balloon catheter
Time Frame
Day 0 until day 1 (<24 h)
Title
Safety parameters potentially related to the use of the investigational medical device
Description
Incidence, frequency, severity, seriousness and relatedness of adverse events/effects are recorded.
Time Frame
Day 0 until day 30
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
University Hospitals Leuven
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Evaluation of the VIPUN Balloon Catheter 0.2 in Critically Ill Patients
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