Retention of Nasoenteric Feeding Tubes in Pediatric Patients Using a Nasal Bridle
Purpose
A study to compare tube dislodgment rates when a nasoenteric feeding tube is secured with adhesive tape vs the AMT BridlePro device.
Condition
- Feeding Tube Complication
Eligibility
- Eligible Ages
- Under 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Active Comparator Nasal bridle to secure feeding tube |
The nasal bridle will be used to secure the nasoenteric feeding tube. |
|
Placebo Comparator Adhesive Tape use to secure feeding tube |
Adhesive tape will be used as standard of care to secure the nasoenteric feeding tube. |
|
More Details
- Status
- Completed
- Sponsor
- The University of Texas Health Science Center at San Antonio
Study Contact
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.