Nasogastric Tube Securement Comparison Study

Not Applicable

Completed

• Conditions: Bowel Obstruction; Constipation; Feeding and Eating Disorders; Failure to Thrive; Nutritional Deficiency
• Interventions: Device: Nasal Bridle

• Registration Number: NCT03202576
• Lead Sponsor: University of Colorado, Denver

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.

Study Timeline

• Study Start: 2016-10-01
• Study First Submitted: 2017-06-12
• Study First Submitted QC: 2017-06-27
• Study First Posted: 2017-06-28
• Primary Completion: 2020-03-31
• Study Completion: 2020-08-20
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-15
• Last Update Posted: 2020-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nasogastric Tube Nasal Bridle Securement	Nasal Bridle	Securement of NG with AMT Micro Bridle

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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