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CompletedNCT03202576NTSNBUpdated Dec 17, 2020

Nasogastric Tube Securement Comparison Study

An interventional study of Nasal Bridle in Failure to Thrive, Nutritional Deficiency and Constipation, sponsored by University of Colorado, Denver. Completed. Open to participants aged 1 Day to 21 Years. Per ClinicalTrials.gov, last updated 2020-12-17.

Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
43
Allocation
Randomized
Ages
1 Day to 21 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

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

Keywords

  • nasogastric tube
  • microbridle
03

Who can participate

Ages eligible
1 Day to 21 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
43 participants (actual)

Study arms

  • 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

Interventions

  • DeviceNasal 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.

    Also known as: Microbridle

05

What researchers measure

Primary outcomes

  1. 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

  1. Device usability

    Ease of use of the nasal bridle device

    Time frame: Up to 4 weeks

  2. Radiation exposure

    Number of X-rays to confirm tube placement.

    Time frame: Up to 4 weeks

  3. Cost

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

    Time frame: Up to 4 weeks

  4. Restraint use

    Use of restraints for the purpose of tube protection.

    Time frame: Up to 4 weeks

  5. Skin integrity

    Skin integrity: complications/issues

    Time frame: Up to 4 weeks

  6. Patient/Caregiver Satisfaction

    Patient/caregiver satisfaction with bridle.

    Time frame: Up to 4 weeks

06

Study locations

No study locations are listed for this record.

07

References and documents

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. PubMed 25606648 ↗
  • 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. PubMed 24440003 ↗
  • 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. PubMed 18827069 ↗
  • 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. PubMed 23455863 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03202576
Lead sponsor
University of Colorado, Denver
Responsible party
Sponsor
First posted
Jun 28, 2017
Start date
Oct 1, 2016
Primary completion
Mar 31, 2020
Completion
Aug 20, 2020
Last update
Dec 17, 2020

Study contacts

Ashley Banks (Taubert-Dupey), BSN
principal investigator · Childrens Hospital Colorado

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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