Retention of Nasoenteric Feeding Tubes in Pediatric Patients Using a Nasal Bridle

Improving Retention of Nasoenteric Feeding Tubes in Pediatric Patients Using a Nasal Bridle

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

Study Overview

• Status: Completed
• Conditions: Feeding Tube Complication
• Intervention / Treatment: Device: AMT BridlePro Device; Device: Adhesive Tape

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • University Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 16 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Tube Dislodgements Per 10 Tube Days.	The number of times the tube is dislodged for every 10 days of feeding tubes.	10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to dislodgement	Measurement of time until nasoenteric tube is dislodged and needs to be repositioned	Period of hospitalization (no more than 30 days)
Number of radiographs for tube replacement	Number of X-rays required to reposition tube.	Period of hospitalization (no more than 30 days)
Cost of replacement tubes and follow up radiographs	Extra costs involved in replacing tubes and performing radiographs	Period of hospitalization (no more than 30 days)
Time of missed nutrition	Amount of time that nutrition was missed due to tube replacement	Period of hospitalization (no more than 30 days)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center at San Antonio
• Investigators: Principal Investigator: Veronica Armijo, MD, University of Texas Health at San Antonio

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2020
• Primary Completion (Actual): April 30, 2021
• Study Completion (Actual): September 16, 2021

Study Registration Dates

• First Submitted: November 3, 2020
• First Submitted That Met QC Criteria: November 3, 2020
• First Posted (Actual): November 9, 2020

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 7, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: HSC20190225H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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