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

Study Overview
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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.

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.

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

Conditions
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Feeding Tube Complication

Intervention / Treatment
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* Device: AMT BridlePro Device
* Device: Adhesive Tape


Participation Criteria
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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 Does not meet inclusion criteria

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nasal bridle to secure feeding tube<br>The nasal bridle will be used to secure the nasoenteric feeding tube. | Device: AMT BridlePro Device<br>* A device used as an alternative securement method using the structure of the nasal cavity to secure the nasoenteric tube.<br>* Other names: Applied Medical Technology (AMT) BridlePro Device;|
| Placebo Comparator: Adhesive Tape use to secure feeding tube<br>Adhesive tape will be used as standard of care to secure the nasoenteric feeding tube. | Device: Adhesive Tape<br>* Adhesive tape used to secure nasoenteric tube<br>* Other names: Tape;|

What is the study measuring?
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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 |