LEGEND: Placement of Novel Endoscopic Enteral Feeding Tube

Sponsor

Nestlé (Industry)

Overall Status

Terminated

CT.gov ID

NCT03520582

Collaborator

(none)

Enrollment

Location

8.7

Actual Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers Enteral Feeding	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 Design

Study Type:

Observational

Actual Enrollment :

12 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

Placement of Novel Endoscopic Enteral Feeding Tube - A Feasibility Study

Actual Study Start Date :

Nov 6, 2017

Actual Primary Completion Date :

Jun 7, 2018

Actual Study Completion Date :

Jul 30, 2018

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 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 patients: Time required to reach gastric and postpyloric placement [During Intervention Visit, an average of 24 hours]
Questionnaire
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitätsklinik für Intensivmedizin	Bern		Switzerland	3010

Sponsors and Collaborators

Nestlé

Investigators

Principal Investigator: Tobias Merz, Dr. med., Inselspital Bern, Universitätsklinik für Intensivmedizin

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nestlé

ClinicalTrials.gov Identifier:

NCT03520582

Other Study ID Numbers:

16.22.CLI

First Posted:

May 11, 2018

Last Update Posted:

Sep 7, 2018

Last Verified:

Sep 1, 2018

Study Results

No Results Posted as of Sep 7, 2018