Trials / Completed
CompletedNCT04621734
Retention of Nasoenteric Feeding Tubes in Pediatric Patients Using a Nasal Bridle
Improving Retention of Nasoenteric Feeding Tubes in Pediatric Patients Using a Nasal Bridle
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 35 (actual)
- Sponsor
- The University of Texas Health Science Center at San Antonio · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | AMT BridlePro Device | A device used as an alternative securement method using the structure of the nasal cavity to secure the nasoenteric tube. |
| DEVICE | Adhesive Tape | Adhesive tape used to secure nasoenteric tube |
Timeline
- Start date
- 2020-02-18
- Primary completion
- 2021-04-30
- Completion
- 2021-09-16
- First posted
- 2020-11-09
- Last updated
- 2023-08-14
- Results posted
- 2023-08-14
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04621734. Inclusion in this directory is not an endorsement.