Healthy Volunteers Clinical Trial
Official title:
Placement of Novel Endoscopic Enteral Feeding Tube - A Feasibility Study
The aim of this study is to evaluate the technical feasibility of the new tube placement technology in healthy volunteers and, if proven feasible, in critically ill patients requiring placement of a feeding tube.
Enteral feeding is the preferred route of nutrient delivery in hospitalized patients who
cannot eat sufficiently. Placement of enteral feeding tubes carries a risk of misplacement
especially in patients who are unable to fully collaborate during the tube placement due to
neurological impairment and/or the presence of an artificial airway. The misplacement of a
feeding tube in the airways has a high risk of severe complications, including pneumonia,
mechanical damage of airways and the lung, and death. The verification of correct tube
placement can be done using radiography, or interventions aimed at confirming the location of
the tube tip by aspiration of gastric contents, and by auscultation during injection of air.
Approximately 20-25 % of patients treated in intensive care units are likely to need
placement of a feeding tube, while undergoing mechanical ventilation and having an artificial
airway. This high risk patient group would benefit from technologies allowing direct
visualization of tube placement. It is also expected that direct visualization of tube
placement will allow confirmation of tube placement and therefore eliminate the need of
radiography (radiation).
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