Clinical Evaluation of the VIPUN Balloon Catheter 0.2 in Critically Ill Patients

Critical Illness Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03512145
• Other study ID #: S61147
• Status: Completed
• Phase: N/A
• Start date: April 16, 2018
• Est. completion date: August 30, 2019

Study information

• Verified date: August 2019
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

An open label, non-randomized, monocentric, interventional investigation in a cohort of adult critically ill patients

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 30, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Critical Illness
• Delayed Gastric Emptying
• Gastric Motor Dysfunction
• Gastroparesis
• Intolerance; Nutritional

Intervention

Device:
• VIPUN Balloon Catheter
Gastric motility is recorded continuously with the VIPUN Balloon Catheter for 10 hours.

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Prof Dr Jan Tack

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastric motility	Assessed with the VIPUN Balloon Catheter	10 hours
Primary	gastric emptying rate	Assessed with 13C-octanoate breath test	6 hours
Secondary	Success rate placement and removal balloon catheter	Success rate completing the procedures to place and remove the balloon catheter	Day 0 until day 1 (<24 h)
Secondary	Safety parameters potentially related to the use of the investigational medical device	Incidence, frequency, severity, seriousness and relatedness of adverse events/effects are recorded.	Day 0 until day 30