Case Series to Evaluate the Identification of Anatomical Markers Using the KANGAROO™ Feeding Tube

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

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

Study Overview

• Status: Completed
• Conditions: Enteral Nutrition, Feeding Tube Placement

• Study Type: Observational
• Enrollment (Actual): 49

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients requiring nasogastric feeding tube in an ICU or step-down unit

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The ability of the clinician to recognize anatomical markers in the gastrointestinal tract using the IRIS feeding tube	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	during the feeding tube placement procedure

Collaborators and Investigators

• Sponsor: Medtronic - MITG
• Investigators: Principal Investigator: Paul Wischmeyer, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: April 27, 2015
• First Submitted That Met QC Criteria: April 27, 2015
• First Posted (Estimate): April 30, 2015

Study Record Updates

• Last Update Posted (Estimate): November 30, 2016
• Last Update Submitted That Met QC Criteria: November 29, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: COVIRIS0465

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No