Nasogastric Tube Securement Comparison Study

Study Overview
=================
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.

Official Title
-----------------
Nasogastric Tube Securement: Comparison of Standard Practice Versus Nasal Bridle for Pediatric Hospitalized Patients

Conditions
-----------------
Failure to Thrive, Nutritional Deficiency, Constipation, Bowel Obstruction, Feeding and Eating Disorders

Intervention / Treatment
-----------------
* Device: Nasal Bridle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Require a nasogastric or transpyloric tube (Corpak tube or clear feeding tube) for feeding or bowel cleanout. Predicted length of use is at least 48 hours. Newborn up to 21 years of age Have a completed consent for enrollment into the study. Exclusion Criteria: Burn patients because standard for placement is the nasal bridle; 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 Any tubes placed for decompression (i.e. Salem Sump tubes) Nasally intubated, or With CPAP/BiPAP.

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Evaluate the securement of the Nasogastric tube either by standard securement or using a Nasal Bridal securement method.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Nasogastric tube standard securement<br>Standard securement of nasogastric tube with adhesive tape | |
| Experimental: Nasogastric Tube Nasal Bridle Securement<br>Securement of NG with AMT Micro Bridle | Device: Nasal Bridle<br>* 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.<br>* Other names: Microbridle;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tube dislodgment | 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. | Up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device usability | Ease of use of the nasal bridle device | Up to 4 weeks | 
| Radiation exposure | Number of X-rays to confirm tube placement. | Up to 4 weeks | 
| Cost | Average costs among groups related to naso-gastric (NG) tube placement and replacement | Up to 4 weeks | 
| Restraint use | Use of restraints for the purpose of tube protection. | Up to 4 weeks | 
| Skin integrity | Skin integrity: complications/issues | Up to 4 weeks | 
| Patient/Caregiver Satisfaction | Patient/caregiver satisfaction with bridle. | Up to 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nasogastric tube, microbridle