Placement of Novel Endoscopic Enteral Feeding Tube

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Placement of Novel Endoscopic Enteral Feeding Tube - A Feasibility Study

Conditions
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Healthy Volunteers, Enteral Feeding

Intervention / Treatment
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* Device: Tube placement


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Volunteers<br>Cohort of 10 healthy subjects. The tube will be placed and removed by a gastroenterologist experienced in performing endoscopic postpyloric tube placement. Secondly, a second tube will be placed and removed. | Device: Tube placement<br>* Placement of enteral feeding tubes<br>|
| Mechanically ventilated ICU<br>Cohort of 20 mechanically ventilated intensive care patients requiring a placement of a postpyloric feeding tube on clinical indications. | Device: Tube placement<br>* Placement of enteral feeding tubes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | During Intervention Visit, an average of 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In healthy volunteers, time required to reach gastric and postpyloric placement | Questionnaire with various positions and the time to reach the position | During Intervention Visit, an average of 24 hours | 
| In healthy volunteers, ease of insertion, handling, and image quality assessed | Using a visual analog scale of 1-10, with 1 indicating the best value | During Intervention Visit, an average of 24 hours | 
| In healthy volunteers, Usability of specific features - tip steerability, lens rinsing and flushing, air insufflation and fluid extraction | Using a visual analog scale of 1-10, with 1 indicating the best value. | During Intervention Visit, an average of 24 hours | 
| In patients: Necessity of use of additional sedation/analgesia for the procedure in addition to already established sedation in the context of mechanical ventilation. | Questionnaire Yes/No and a visual analog scale of 1-10, with 1 indicating the best value | During Intervention Visit, an average of 24 hours | 
| In patients: Ease of insertion, handling, and image quality assessed using a visual analog scale of 1-10, with 1 indicating the best value. | using a visual analog scale of 1-10, with 1 indicating the best value | During Intervention Visit, an average of 24 hours | 
| In patients: Usability of specific features - tip steerability, lens rinsing and flushing, air insufflation and fluid extraction. | using a visual analog scale of 1-10, with 1 indicating the best value | During Intervention Visit, an average of 24 hours | 
| In patients: Subjective global assessment of the intensivist on whether or not the technique is suitable for clinical use in patients. | using a visual analog scale of 1-10, with 1 indicating the best value | During Intervention Visit, an average of 24 hours | 
| In patients: Time required to reach gastric and postpyloric placement | Questionnaire | During Intervention Visit, an average of 24 hours | 
| In patients: Feasibility of the feeding through Veritract tube. | using a visual analog scale of 1-10, with 1 indicating the best value | During Intervention Visit, an average of 24 hours | 
| Bleeding and infection related to tube placement | AE/SAE Questionnaire Yes/No | During Intervention Visit, an average of 24 hours | 
| Erroneous placement in larynx and trachea and associated complications (pneumothorax). | Outcome mesured with a questionnaire Yes/No | During Intervention Visit, an average of 24 hours | 
| Injuries of the oesophagus, stomach or small intestine related to tube placement. | Outcome mesured with a questionnaire Yes/No | During Intervention Visit, an average of 24 hours | 
| Reflux of stomach contents during tube placement | AE/SAE Questionnaire Yes/No | During Intervention Visit, an average of 24 hours |