NCT03202576

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 28, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2020

Completed
Last Updated

December 17, 2020

Status Verified

December 1, 2020

Enrollment Period

3.5 years

First QC Date

June 12, 2017

Last Update Submit

December 15, 2020

Conditions

Failure to ThriveNutritional DeficiencyConstipationBowel ObstructionFeeding and Eating Disorders

Keywords

nasogastric tubemicrobridle

Outcome Measures

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.

    Up to 4 weeks

Secondary Outcomes (6)

  • Device usability

    Up to 4 weeks

  • Radiation exposure

    Up to 4 weeks

  • Cost

    Up to 4 weeks

  • Restraint use

    Up to 4 weeks

  • Skin integrity

    Up to 4 weeks

  • +1 more secondary outcomes

Study Arms (2)

Nasogastric tube standard securement

NO INTERVENTION

Standard securement of nasogastric tube with adhesive tape

Nasogastric Tube Nasal Bridle Securement

EXPERIMENTAL

Securement of NG with AMT Micro Bridle

Device: Nasal Bridle

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.

Also known as: Microbridle
Nasogastric Tube Nasal Bridle Securement

Eligibility Criteria

Age1 Day - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Admitted to Children's Hospital Colorado to:
  • th floor surgical inpatient unit, or
  • th floor medical inpatient unit, or
  • Heart Institute (Cardiac Intensive Care Unit or Cardiac Progressive Care Unit), or
  • Interventional Radiology.
  • Require a nasogastric or transpyloric tube (Corpak tube or clear feeding tube) for feeding or bowel cleanout.
  • Predicted length of use is at least 48 hours.
  • Newborn up to 21 years of age
  • Have a completed consent for enrollment into the study.

You may not qualify if:

  • Burn patients because standard for placement is the nasal bridle;
  • 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
  • Any tubes placed for decompression (i.e. Salem Sump tubes)
  • Nasally intubated, or
  • With CPAP/BiPAP.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 25606648RESULT

  • 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.

    PMID: 24440003RESULT

  • 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.

    PMID: 18827069RESULT

  • 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.

    PMID: 23455863RESULT

MeSH Terms

Conditions

Failure to ThriveMalnutritionConstipationIntestinal ObstructionFeeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsNutrition DisordersNutritional and Metabolic DiseasesSigns and Symptoms, DigestiveIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMental Disorders

Study Officials

  • Ashley Banks (Taubert-Dupey), BSN

    Childrens Hospital Colorado

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Evaluate the securement of the Nasogastric tube either by standard securement or using a Nasal Bridal securement method.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2017

First Posted

June 28, 2017

Study Start

October 1, 2016

Primary Completion

March 31, 2020

Study Completion

August 20, 2020

Last Updated

December 17, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share