Feeding Tube Complication
Conditions
Brief 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.
Interventions
DEVICEAMT BridlePro Device
A device used as an alternative securement method using the structure of the nasal cavity to secure the nasoenteric tube.
DEVICEAdhesive Tape
Adhesive tape used to secure nasoenteric tube
Sponsors
The University of Texas Health Science Center at San Antonio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Tube Dislodgements Per 10 Tube Days. | 10 days | The number of times the tube is dislodged for every 10 days of feeding tubes. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 17 |
| 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 | 18 |
| Total | 35 |
Baseline characteristics
| Characteristic | Nasal Bridle to Secure Feeding Tube | Adhesive Tape Use to Secure Feeding Tube | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 17 Participants | 18 Participants | 35 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 6.5 years | 9.1 years | 7.8 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants | 16 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 2 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 17 participants | 18 participants | 35 participants |
| Sex: Female, Male Female | 5 Participants | 8 Participants | 13 Participants |
| Sex: Female, Male Male | 12 Participants | 10 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 18 |
| other Total, other adverse events | 1 / 17 | 4 / 18 |
| serious Total, serious adverse events | 0 / 17 | 0 / 18 |
Outcome results
Primary
Number of Tube Dislodgements Per 10 Tube Days.
The number of times the tube is dislodged for every 10 days of feeding tubes.
Time frame: 10 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Nasal Bridle to Secure Feeding Tube | Number of Tube Dislodgements Per 10 Tube Days. | 0.16 Dislodgements |
| Adhesive Tape Use to Secure Feeding Tube | Number of Tube Dislodgements Per 10 Tube Days. | 2.11 Dislodgements |