Placement of Novel Endoscopic Enteral Feeding Tube

N/ATerminatedNCT03520582

Société des Produits Nestlé (SPN)12 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Healthy Volunteers Enteral Feeding

Interventions

Tube placementDEVICE

Placement of enteral feeding tubes

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: Healthy volunteers * Informed Consent as documented by signature (Appendix Informed Consent Form) * Age \>18 years Patients * Age \>18 years * mechanically ventilated and requiring a placement of a postpyloric feeding tube on clinical indications * Informed Consent as documented by signature of relatives Exclusion Criteria: Healthy volunteers and patients * Unrepaired tracheoesophageal fistula * history of prior esophageal or gastric surgery * esophageal obstruction, stricture, varices or diverticulum * esophageal or gastric perforation, gastric or esophageal bleeding * recent oropharyngeal surgery * cervical spine injury or anomaly Additional exclusion criterion for patients only • know severe coagulopathy (defined as thrombocyte count less than 30x10e9/l or International Normalized Ratio (INR) \> 3)

Locations (1)

Universitätsklinik für Intensivmedizin

Bern, Switzerland

Outcomes

Primary Outcomes

Success rate of postpyloric placement, time to reach intragastric and postpyloric position, ease of insertion, handling and image quality.

using a visual analog scale of 1-10, with 1 indicating the best value