Enteral Nutrition, Feeding Tube Placement
Conditions
Brief summary
This is a prospective, single-center, open label, within-subject clinical trial to evaluate the identification of anatomical markers in the gastrointestinal tract using the IRIS feeding tube. The trial will evaluate hospitalized subjects who require short-term enteral feeding with an anticipated duration of at least 3 days while in an intensive care unit (ICU) or step-down unit. Eligible men and women at least 18 years of age who give voluntary, written informed consent to participate in the clinical investigation will be included as subjects. If a potential subject is incapacitated and unable to provide informed consent, a designated legally authorized representative will be allowed to provide the informed consent on behalf of the subject to allow their participation in the study. Study entry will be defined as the point of signed informed consent. A Prospective, Single-Center, Open Label, Within-Subject Case Series to Evaluate the Identification of Anatomical Markers in the Gastrointestinal Tract Using the KANGAROO™ Feeding Tube with IRIS Technology
Interventions
None listed
Sponsors
Medtronic - MITG
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Hospitalized male and female patients in a monitored setting (i.e.; ICU or Step-Down Unit) who require and are eligible for short-term enteral (nasal or oral) feeding per standard of care with an expected duration of at least 3 days. 2. The subject or a legally authorized representative is able to understand and willing to give written informed consent. 3. Be a man or woman of 18 years or older 4. Have uncomplicated naso- and oropharyngeal anatomy based upon a focused physical examination
Exclusion criteria
1. Women and men under the age of 18 years 2. Female patients who are known to be pregnant or lactating 3. Incarcerated or imprisoned individuals 4. Hemodynamic instability with an inability to maintain a MAP \> 65 mm Hg on vasopressors 5. Patients who are currently enrolled in an investigational or interventional drug or device clinical trial 6. Patients who have been previously enrolled into this study 7. Individuals, who, in the opinion of the Principal Investigator, have any medical, social or psychological condition that would compromise their participation and follow-up in this clinical investigation 8. Known basal skull fractures 9. Unrepaired known GI perforation or leak 10. Recent adequate upper GI bleed that may obscure images 11. Esophageal varices \> Grade 2 12. Subjects with known anomalies precluding gastric or intestinal insertion (via either nasally or orally) 13. Known obstruction of the gastrointestinal tract 14. Known bowel ischemia or any other contraindication for enteral feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The ability of the clinician to recognize anatomical markers in the gastrointestinal tract using the IRIS feeding tube | during the feeding tube placement procedure | the following anatomical structures will be noted if visualized and the depth of feeding tube will also be recorded corresponding to the visualized structure: trachea/carina, esophagus, stomach |
Countries
United States
Outcome results
None listed