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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nasal bridle to secure feeding tube | Active Comparator | The nasal bridle will be used to secure the nasoenteric feeding tube. |
|
| Adhesive Tape use to secure feeding tube | Placebo Comparator | Adhesive tape will be used as standard of care to secure the nasoenteric feeding tube. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMT BridlePro Device | Device | A device used as an alternative securement method using the structure of the nasal cavity to secure the nasoenteric tube. |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Veronica Armijo, MD | University of Texas Health at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Health System | San Antonio | Texas | 78229 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40369642 | Derived | Foster M, Armijo-Garcia V, Gelfond J, Meyer AD. Improving retention of pediatric feeding tubes with a nasal bridle: a randomized controlled trial. Trials. 2025 May 14;26(1):159. doi: 10.1186/s13063-025-08867-x. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nasal Bridle to Secure Feeding Tube | The nasal bridle will be used to secure the nasoenteric feeding tube. AMT BridlePro Device: A device used as an alternative securement method using the structure of the nasal cavity to secure the nasoenteric tube. |
| FG001 | Adhesive Tape Use to Secure Feeding Tube | Adhesive tape will be used as standard of care to secure the nasoenteric feeding tube. Adhesive Tape: Adhesive tape used to secure nasoenteric tube |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nasal Bridle to Secure Feeding Tube | The nasal bridle will be used to secure the nasoenteric feeding tube. AMT BridlePro Device: A device used as an alternative securement method using the structure of the nasal cavity to secure the nasoenteric tube. |
| BG001 | Adhesive Tape Use to Secure Feeding Tube |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Tube Dislodgements Per 10 Tube Days. | The number of times the tube is dislodged for every 10 days of feeding tubes. | Posted | Mean | Full Range | Dislodgements | 10 days |
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nasal Bridle to Secure Feeding Tube | The nasal bridle will be used to secure the nasoenteric feeding tube. AMT BridlePro Device: A device used as an alternative securement method using the structure of the nasal cavity to secure the nasoenteric tube. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin Breakdown | Skin and subcutaneous tissue disorders | Systematic Assessment | Skin breakdown at the site of the bridle or adhesive tape |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Veronica Armijo-Garcia | University of Texas Health Science Center at San Antonio | 210-274-8969 | mirelesv@uthscsa.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 9, 2020 | Aug 25, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D053832 | Surgical Tape |
| ID | Term |
|---|---|
| D053831 | Surgical Fixation Devices |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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|
| Adhesive Tape | Device | Adhesive tape used to secure nasoenteric tube |
|
|
Adhesive tape will be used as standard of care to secure the nasoenteric feeding tube. Adhesive Tape: Adhesive tape used to secure nasoenteric tube |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 1 |
| 17 |
| EG001 | Adhesive Tape Use to Secure Feeding Tube | Adhesive tape will be used as standard of care to secure the nasoenteric feeding tube. Adhesive Tape: Adhesive tape used to secure nasoenteric tube | 0 | 18 | 0 | 18 | 4 | 18 |
|
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