Clinical trial NCT02430571: Case Series to Evaluate the Identification of Anatomical Markers Using the KANGAROO™ Feeding Tube
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Enteral Nutrition, Feeding Tube Placement
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2015-04-30
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients requiring nasogastric feeding tube in an ICU or step-down unit

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


Eligibility criteria: 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

Primary outcomes:
measure: The ability of the clinician to recognize anatomical markers in the gastrointestinal tract using the IRIS feeding tube
timeFrame: during the feeding tube placement procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado School of Medicine
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Paul Wischmeyer, MD
role: PRINCIPAL_INVESTIGATOR
References: