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

Not Applicable

Completed

• Conditions: Feeding Tube Complication
• Interventions: Device: AMT BridlePro Device; Device: Adhesive Tape

• Registration Number: NCT04621734
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

Brief Summary

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

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 Timeline

• Study Start: 2020-02-18
• Study First Submitted: 2020-11-03
• Study First Submitted QC: 2020-11-03
• Study First Posted: 2020-11-09
• Primary Completion: 2021-04-30
• Study Completion: 2021-09-16
• Results First Submitted: 2023-01-08
• Status Verified: 2023-08
• Results First Submitted QC: 2023-08-07
• Last Update Submitted: 2023-08-07
• Results First Posted: 2023-08-14
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nasal bridle to secure feeding tube	AMT BridlePro Device	The nasal bridle will be used to secure the nasoenteric feeding tube.
Adhesive Tape use to secure feeding tube	Adhesive Tape	Adhesive tape will be used as standard of care to secure the nasoenteric feeding tube.

Primary Outcome Measures

Name	Time	Method
Number of Tube Dislodgements Per 10 Tube Days.	10 days	The number of times the tube is dislodged for every 10 days of feeding tubes.

Trial Locations

Locations (1)

University Health System; 🇺🇸 San Antonio, Texas, United States