Enteral Feeding, Healthy Volunteers
Conditions
Brief summary
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
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).
Interventions
DEVICETube placement
Placement of enteral feeding tubes
Sponsors
Société des Produits Nestlé (SPN)
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success rate of postpyloric placement, time to reach intragastric and postpyloric position, ease of insertion, handling and image quality. | During Intervention Visit, an average of 24 hours | using a visual analog scale of 1-10, with 1 indicating the best value |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| In healthy volunteers, ease of insertion, handling, and image quality assessed | During Intervention Visit, an average of 24 hours | Using a visual analog scale of 1-10, with 1 indicating the best value |
| In healthy volunteers, Usability of specific features - tip steerability, lens rinsing and flushing, air insufflation and fluid extraction | During Intervention Visit, an average of 24 hours | Using a visual analog scale of 1-10, with 1 indicating the best value. |
| In patients: Necessity of use of additional sedation/analgesia for the procedure in addition to already established sedation in the context of mechanical ventilation. | During Intervention Visit, an average of 24 hours | Questionnaire Yes/No and a visual analog scale of 1-10, with 1 indicating the best value |
| In patients: 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 | using a visual analog scale of 1-10, with 1 indicating the best value |
| In patients: Usability of specific features - tip steerability, lens rinsing and flushing, air insufflation and fluid extraction. | During Intervention Visit, an average of 24 hours | using a visual analog scale of 1-10, with 1 indicating the best value |
| In patients: Subjective global assessment of the intensivist on whether or not the technique is suitable for clinical use in patients. | During Intervention Visit, an average of 24 hours | using a visual analog scale of 1-10, with 1 indicating the best value |
| In healthy volunteers, time required to reach gastric and postpyloric placement | During Intervention Visit, an average of 24 hours | Questionnaire with various positions and the time to reach the position |
| In patients: Feasibility of the feeding through Veritract tube. | During Intervention Visit, an average of 24 hours | using a visual analog scale of 1-10, with 1 indicating the best value |
| Bleeding and infection related to tube placement | During Intervention Visit, an average of 24 hours | AE/SAE Questionnaire Yes/No |
| Erroneous placement in larynx and trachea and associated complications (pneumothorax). | During Intervention Visit, an average of 24 hours | Outcome mesured with a questionnaire Yes/No |
| Injuries of the oesophagus, stomach or small intestine related to tube placement. | During Intervention Visit, an average of 24 hours | Outcome mesured with a questionnaire Yes/No |
| Reflux of stomach contents during tube placement | During Intervention Visit, an average of 24 hours | AE/SAE Questionnaire Yes/No |
| In patients: Time required to reach gastric and postpyloric placement | During Intervention Visit, an average of 24 hours | Questionnaire |
Countries
Switzerland
Outcome results
None listed