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

Feeding Tube Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04621734
• Other study ID #: HSC20190225H
• Status: Completed
• Phase: N/A
• Start date: February 18, 2020
• Est. completion date: September 16, 2021

Study information

• Verified date: August 2023
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: September 16, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Feeding Tube Complication

Intervention

Device:
• AMT BridlePro Device
A device used as an alternative securement method using the structure of the nasal cavity to secure the nasoenteric tube.
• Adhesive Tape
Adhesive tape used to secure nasoenteric tube

Locations

Country	Name	City	State
United States	University Health System	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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