Nasogastric Tube Securement Comparison Study

N/ACompletedNCT03202576

University of Colorado, Denver43 enrolled

Overview

This study evaluates the use of tape to secure nasogastric tubes compared to securement with a nasal bridle device.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

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

Interventions

Nasal BridleDEVICE

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.

Eligibility

Sex: ALLMin age: 1 DayMax age: 21 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: Up to 4 weeks

Secondary Outcomes

Device usability

Ease of use of the nasal bridle device

Time frame: Up to 4 weeks

Radiation exposure

Number of X-rays to confirm tube placement.

Time frame: Up to 4 weeks

Cost

Average costs among groups related to naso-gastric (NG) tube placement and replacement

Time frame: Up to 4 weeks

Restraint use

Use of restraints for the purpose of tube protection.

Time frame: Up to 4 weeks

Skin integrity

Skin integrity: complications/issues

Time frame: Up to 4 weeks

Patient/Caregiver Satisfaction

Patient/caregiver satisfaction with bridle.

Time frame: Up to 4 weeks

Data from ClinicalTrials.gov

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