Nasogastric Tube Securement Comparison Study (NTSNB)

University of Colorado Denver (CU Denver)

Status: Completed

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

Treatments: Device: Nasal Bridle

Study type: Interventional

Funder types: Other

Identifiers

NCT03202576

16-0691

Details and patient eligibility

About

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

Full 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.

Enrollment: 43 patients

Sex: All

Ages: 1 day to 21 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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43 participants in 2 patient groups

Nasogastric tube standard securement

No Intervention group

Description:

Standard securement of nasogastric tube with adhesive tape

Nasogastric Tube Nasal Bridle Securement

Experimental group

Description:

Securement of NG with AMT Micro Bridle

Treatment:

Device: Nasal Bridle