Nasogastric Tube Securement Comparison Study

Constipation Clinical Trial

— NTSNB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03202576
• Other study ID #: 16-0691
• Status: Completed
• Phase: N/A
• Start date: October 1, 2016
• Est. completion date: August 20, 2020

Study information

• Verified date: December 2020
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: August 20, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

References & 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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Device usability	Ease of use of the nasal bridle device	Up to 4 weeks
Secondary	Radiation exposure	Number of X-rays to confirm tube placement.	Up to 4 weeks
Secondary	Cost	Average costs among groups related to naso-gastric (NG) tube placement and replacement	Up to 4 weeks
Secondary	Restraint use	Use of restraints for the purpose of tube protection.	Up to 4 weeks
Secondary	Skin integrity	Skin integrity: complications/issues	Up to 4 weeks
Secondary	Patient/Caregiver Satisfaction	Patient/caregiver satisfaction with bridle.	Up to 4 weeks