Placement of Novel Endoscopic Enteral Feeding Tube

NCT ID: NCT03520582

Last Updated: 2018-09-07

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 12 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-11-06
• Study Completion Date: 2018-07-30

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).

Conditions

Healthy Volunteers; Enteral Feeding

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

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.

Tube placement

Intervention Type: DEVICE

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.

Tube placement

Intervention Type: DEVICE

Placement of enteral feeding tubes

Interventions

Tube placement

Placement of enteral feeding tubes

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tobias Merz, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Inselspital Bern, Universitätsklinik für Intensivmedizin

Locations

Universitätsklinik für Intensivmedizin

Bern, , Switzerland

Countries

Switzerland

Other Identifiers

16.22.CLI

Identifier Type: -

Identifier Source: org_study_id