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Nasogastric Tube Securement Comparison Study

NCT ID: NCT03202576

Last Updated: 2020-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-01

Study Completion Date

2020-08-20

Brief Summary

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

Detailed Description

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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.

Conditions

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

Keywords

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nasogastric tube microbridle

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Evaluate the securement of the Nasogastric tube either by standard securement or using a Nasal Bridal securement method.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Nasogastric tube standard securement

Standard securement of nasogastric tube with adhesive tape

Group Type NO_INTERVENTION

No interventions assigned to this group

Nasogastric Tube Nasal Bridle Securement

Securement of NG with AMT Micro Bridle

Group Type EXPERIMENTAL

Nasal Bridle

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Microbridle

Eligibility Criteria

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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.
Minimum Eligible Age

1 Day

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ashley Banks (Taubert-Dupey), BSN

Role: PRINCIPAL_INVESTIGATOR

Childrens Hospital Colorado

References

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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.

Reference Type RESULT
PMID: 25606648 (View on PubMed)

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.

Reference Type RESULT
PMID: 24440003 (View on PubMed)

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.

Reference Type RESULT
PMID: 18827069 (View on PubMed)

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.

Reference Type RESULT
PMID: 23455863 (View on PubMed)

Other Identifiers

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16-0691

Identifier Type: -

Identifier Source: org_study_id