Clinical Evaluation of the VIPUN Balloon Catheter 0.2 in Critically Ill Patients (ANTERO-2)

Prof Dr Jan Tack

Status: Completed

Conditions: Intolerance; Nutritional; Critical Illness; Delayed Gastric Emptying; Gastric Motor Dysfunction

Treatments: Device: VIPUN Balloon Catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT03512145

S61147

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

VIPUN Balloon Catheter

Experimental group

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.

Treatment:

Device: VIPUN Balloon Catheter