Purpose

A study to compare tube dislodgment rates when a nasoenteric feeding tube is secured with adhesive tape vs the AMT BridlePro device.

Condition

Eligibility

Eligible Ages
Under 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Need for nasoenteric feeding - Admitted to University Hospital - Age 0-18 years

Exclusion Criteria

  • Facial trauma - Nasal airway obstructions - Thrombocytopenia (<100 K/μL) - s/p septoplasty - Patients with vomer bone graft - Nasoenteric feeding tube placed and secured prior to being screened for study - Contraindication for the use of the BridlePro - Does not meet inclusion criteria

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Nasal bridle to secure feeding tube
The nasal bridle will be used to secure the nasoenteric feeding tube.
  • Device: AMT BridlePro Device
    A device used as an alternative securement method using the structure of the nasal cavity to secure the nasoenteric tube.
    Other names:
    • Applied Medical Technology (AMT) BridlePro Device
Placebo Comparator
Adhesive Tape use to secure feeding tube
Adhesive tape will be used as standard of care to secure the nasoenteric feeding tube.
  • Device: Adhesive Tape
    Adhesive tape used to secure nasoenteric tube
    Other names:
    • Tape

Recruiting Locations

University Health System
San Antonio, Texas 78229
Contact:
Megan Foster, MD
210-415-9215
fosterm3@uthscsa.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center at San Antonio

Study Contact

Megan Foster, MD
210-415-9215
fosterm3@uthscsa.edu

Detailed Description

The adhesive tape will be the tape available in the unit and will be placed by the nurse or provider at the time of nasoenteric tube placement. The tape will be placed around the tube and secured to the cheek on the side of tube. The tape will be replaced as needed per nursing discretion when soiled or the adhesive properties are failing and this information will be tracked. The AMT BridlePro will be placed by the nurse or provider at the time of nasoenteric tube placement. Placement will use the BridlePro system included in the individual BridlePro packaging. Placement and securement will follow manufacturer recommendations and teaching. The BridlePro encircles the vomer bone of the nasal cavity to secure the tube. Sedation medication may be given per standard of care for nasoenteric tube placement at the discretion of the provider team but no separate or additional sedation medication will be given for securement with adhesive tape or the BridlePro.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.