Skip to main content
OpenTrials
Completed

NCT Number: NCT03512145

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Critical Illness Delayed Gastric Emptying Digestive System Diseases Disease Attributes Gastric Motor Dysfunction Gastrointestinal Diseases Gastroparesis Intolerance; Nutritional Neurologic Manifestations Paralysis Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomach Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

VIPUN Balloon Catheter

Device

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

Primary outcomes

  1. Gastric motility

    Time frame: 10 hours

    Assessed with the VIPUN Balloon Catheter

  2. gastric emptying rate

    Time frame: 6 hours

    Assessed with 13C-octanoate breath test

Secondary outcomes

  1. Success rate placement and removal balloon catheter

    Time frame: Day 0 until day 1 (<24 h)

    Success rate completing the procedures to place and remove the balloon catheter

  2. Safety parameters potentially related to the use of the investigational medical device

    Time frame: Day 0 until day 30

    Incidence, frequency, severity, seriousness and relatedness of adverse events/effects are recorded.

Sponsors and collaborators

Lead sponsor

Prof Dr Jan Tack

Other

Registry information

Official study 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

Acronym: ANTERO-2

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 30, 2018
Registry last updated
Sep 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.