Placement of Novel Endoscopic Enteral Feeding Tube (LEGEND)

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.

Study Overview

• Status: Terminated
• Conditions: Healthy Volunteers; Enteral Feeding
• Intervention / Treatment: Device: Tube placement

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).

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Universitätsklinik für Intensivmedizin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient in ICU mechanically ventilated and requiring a placement of a postpyloric feeding tube

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Volunteers; 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; Placement of enteral feeding tubes
Mechanically ventilated ICU; Cohort of 20 mechanically ventilated intensive care patients requiring a placement of a postpyloric feeding tube on clinical indications.	Device: Tube placement; Placement of enteral feeding tubes

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nestlé
• Investigators: Principal Investigator: Tobias Merz, Dr. med., Inselspital Bern, Universitätsklinik für Intensivmedizin

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2017
• Primary Completion (Actual): June 7, 2018
• Study Completion (Actual): July 30, 2018

Study Registration Dates

• First Submitted: December 22, 2016
• First Submitted That Met QC Criteria: April 26, 2018
• First Posted (Actual): May 11, 2018

Study Record Updates

• Last Update Posted (Actual): September 7, 2018
• Last Update Submitted That Met QC Criteria: September 5, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 16.22.CLI