Nasogastric Tube Securement Comparison Study (NTSNB)

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

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

Study Overview

• Status: Completed
• Conditions: Feeding and Eating Disorders; Constipation; Failure to Thrive; Bowel Obstruction; Nutritional Deficiency
• Intervention / Treatment: Device: Nasal Bridle

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 Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Nasogastric tube standard securement; Standard securement of nasogastric tube with adhesive tape
Experimental: Nasogastric Tube Nasal Bridle Securement; Securement of NG with AMT Micro Bridle	Device: Nasal 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.; 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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Ashley Banks (Taubert-Dupey), BSN, Childrens Hospital Colorado

Publications and helpful links

General Publications

• Bechtold ML, Nguyen DL, Palmer LB, Kiraly LN, Martindale RG, McClave SA. Nasal bridles for securing nasoenteric tubes: a meta-analysis. Nutr Clin Pract. 2014 Oct;29(5):667-71. doi: 10.1177/0884533614536737.
• Brugnolli A, Ambrosi E, Canzan F, Saiani L; Naso-gastric Tube Group. Securing of naso-gastric tubes in adult patients: a review. Int J Nurs Stud. 2014 Jun;51(6):943-50. doi: 10.1016/j.ijnurstu.2013.12.002. Epub 2013 Dec 25.
• Gunn SR, Early BJ, Zenati MS, Ochoa JB. Use of a nasal bridle prevents accidental nasoenteral feeding tube removal. JPEN J Parenter Enteral Nutr. 2009 Jan-Feb;33(1):50-4. doi: 10.1177/0148607108321704. Epub 2008 Sep 30.
• Parks J, Klaus S, Staggs V, Pena M. Outcomes of nasal bridling to secure enteral tubes in burn patients. Am J Crit Care. 2013 Mar;22(2):136-42. doi: 10.4037/ajcc2013105.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): March 31, 2020
• Study Completion (Actual): August 20, 2020

Study Registration Dates

• First Submitted: June 12, 2017
• First Submitted That Met QC Criteria: June 27, 2017
• First Posted (Actual): June 28, 2017

Study Record Updates

• Last Update Posted (Actual): December 17, 2020
• Last Update Submitted That Met QC Criteria: December 15, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: nasogastric tube; microbridle
• Additional Relevant MeSH Terms: Mental Disorders; Digestive System Diseases; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Nutrition Disorders; Intestinal Diseases; Feeding and Eating Disorders; Constipation; Malnutrition; Failure to Thrive; Intestinal Obstruction
• Other Study ID Numbers: 16-0691

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No