Bowel Obstruction, Constipation, Failure to Thrive, Feeding and Eating Disorders, Nutritional Deficiency
Conditions
Keywords
nasogastric tube, microbridle
Brief summary
This study evaluates the use of tape to secure nasogastric tubes compared to securement with a nasal bridle device.
Detailed description
Patients who need to have a tube placed through their nose and into their stomach for medical treatments will sometimes have it accidentally removed. A nasal bridle is a device where a magnetic is used to attach a small piece of cloth tape that loops around the nasal septum bone and secures to the nasal gastric tube to prevent it from being pulled out accidentally.
Interventions
DEVICENasal Bridle
Nasal bridle placement and securement of the tube. Instead of taping the tube to the patient's face, nose or upper lip the bridle is a device whereby a magnetic retrieval system is attached to 1/8 inch umbilical tape which is inserted via the nares, looping around the nasal septum and vomer bone and ending with both ends of the bridle (umbilical tape) secured together and to the feeding tube just outside the nose.
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Evaluate the securement of the Nasogastric tube either by standard securement or using a Nasal Bridal securement method.
Eligibility
Sex/Gender
ALL
Age
1 Days to 21 Years
Healthy volunteers
No
Inclusion criteria
1. Admitted to Children's Hospital Colorado to: * 6th floor surgical inpatient unit, or * 8th floor medical inpatient unit, or * Heart Institute (Cardiac Intensive Care Unit or Cardiac Progressive Care Unit), or * Interventional Radiology. 2. Require a nasogastric or transpyloric tube (Corpak tube or clear feeding tube) for feeding or bowel cleanout. 3. Predicted length of use is at least 48 hours. 4. Newborn up to 21 years of age 5. Have a completed consent for enrollment into the study.
Exclusion criteria
1. Burn patients because standard for placement is the nasal bridle; 2. Patients with contraindications for bridle placement , such as * mechanical obstruction of the nasal airway * facial or nasal fractures * fracture of the anterior part of the cranium, or basilar skull fractures 3. Any tubes placed for decompression (i.e. Salem Sump tubes) 4. Nasally intubated, or 5. With CPAP/BiPAP.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tube dislodgment | Up to 4 weeks | Compare the rate/percent of nasogastric tube dislodgement utilizing standard tube securement practice vs. nasal bridle (micro bridle) tube securement device in pediatric hospitalized patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiation exposure | Up to 4 weeks | Number of X-rays to confirm tube placement. |
| Cost | Up to 4 weeks | Average costs among groups related to naso-gastric (NG) tube placement and replacement |
| Device usability | Up to 4 weeks | Ease of use of the nasal bridle device |
| Skin integrity | Up to 4 weeks | Skin integrity: complications/issues |
| Patient/Caregiver Satisfaction | Up to 4 weeks | Patient/caregiver satisfaction with bridle. |
| Restraint use | Up to 4 weeks | Use of restraints for the purpose of tube protection. |
Outcome results
None listed