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

The University of Texas System (UT)

Status: Completed

Conditions: Feeding Tube Complication

Treatments: Device: AMT BridlePro Device; Device: Adhesive Tape

Study type: Interventional

Funder types: Other

Identifiers

NCT04621734

HSC20190225H

Details and patient eligibility

About

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

Full 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.

Enrollment: 35 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 2 patient groups, including a placebo group

Nasal bridle to secure feeding tube

Active Comparator group

Description:

The nasal bridle will be used to secure the nasoenteric feeding tube.

Treatment:

Device: AMT BridlePro Device

Adhesive Tape use to secure feeding tube

Placebo Comparator group

Description:

Adhesive tape will be used as standard of care to secure the nasoenteric feeding tube.

Treatment:

Device: Adhesive Tape