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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-18

Study Completion Date

2021-09-16

Brief Summary

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

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Detailed Description

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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.

Conditions

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Feeding Tube Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nasal bridle to secure feeding tube

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

Group Type ACTIVE_COMPARATOR

AMT BridlePro Device

Intervention Type DEVICE

A device used as an alternative securement method using the structure of the nasal cavity to secure the nasoenteric tube.

Adhesive Tape use to secure feeding tube

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

Group Type PLACEBO_COMPARATOR

Adhesive Tape

Intervention Type DEVICE

Adhesive tape used to secure nasoenteric tube

Interventions

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AMT BridlePro Device

A device used as an alternative securement method using the structure of the nasal cavity to secure the nasoenteric tube.

Intervention Type DEVICE

Adhesive Tape

Adhesive tape used to secure nasoenteric tube

Intervention Type DEVICE

Other Intervention Names

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Applied Medical Technology (AMT) BridlePro Device Tape

Eligibility Criteria

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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

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No