Placement of Novel Endoscopic Enteral Feeding Tube

NCT03520582 | Terminated

• 1 other identifier: 16.22.CLI
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers; Enteral Feeding

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• In healthy volunteers, time required to reach gastric and postpyloric placement

  During Intervention Visit, an average of 24 hours

• In healthy volunteers, ease of insertion, handling, and image quality assessed

  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

  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.

  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.

  During Intervention Visit, an average of 24 hours

Study Arms (2)

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

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

Interventions

Tube placement DEVICE

Placement of enteral feeding tubes

Mechanically ventilated ICU; Volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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
• know severe coagulopathy (defined as thrombocyte count less than 30x10e9/l or International Normalized Ratio (INR) \> 3)

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Universitätsklinik für Intensivmedizin

Bern, 3010, Switzerland

Location

Study Officials

• Tobias Merz, Dr. med.

  Inselspital Bern, Universitätsklinik für Intensivmedizin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2016
• First Posted: May 11, 2018
• Study Start: November 6, 2017
• Primary Completion: June 7, 2018
• Study Completion: July 30, 2018
• Last Updated: September 7, 2018

Record last verified: 2018-09

Locations

CH (1)