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

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

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

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)