Placement of Novel Endoscopic Enteral Feeding Tube

Healthy Volunteers Clinical Trial

— LEGEND  

Official title:

Placement of Novel Endoscopic Enteral Feeding Tube - A Feasibility Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03520582
• Other study ID #: 16.22.CLI
• Status: Terminated
• Start date: November 6, 2017
• Est. completion date: July 30, 2018

Study information

• Verified date: September 2018
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: July 30, 2018
• Est. primary completion date: June 7, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Enteral Feeding
• Healthy Volunteers

Intervention

Device:
• Tube placement
Placement of enteral feeding tubes

Locations

Country	Name	City	State
Switzerland	Universitätsklinik für Intensivmedizin	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	In patients: Time required to reach gastric and postpyloric placement	Questionnaire	During Intervention Visit, an average of 24 hours
Secondary	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
Secondary	Bleeding and infection related to tube placement	AE/SAE Questionnaire Yes/No	During Intervention Visit, an average of 24 hours
Secondary	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
Secondary	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
Secondary	Reflux of stomach contents during tube placement	AE/SAE Questionnaire Yes/No	During Intervention Visit, an average of 24 hours