Clinical trial NCT03202576: Nasogastric Tube Securement Comparison Study
Official title: Nasogastric Tube Securement: Comparison of Standard Practice Versus Nasal Bridle for Pediatric Hospitalized Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Failure to Thrive
Nutritional Deficiency
Constipation
Bowel Obstruction
Feeding and Eating Disorders
Keywords: nasogastric tube
microbridle
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2017-06-28
Enrollment: 43
Sex: ALL
Minimum age (years): 1
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Evaluate the securement of the Nasogastric tube either by standard securement or using a Nasal Bridal securement method.
Primary purpose: HEALTH_SERVICES_RESEARCH

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Tube dislodgment
timeFrame: Up to 4 weeks
Secondary outcomes:
measure: Device usability
timeFrame: Up to 4 weeks
measure: Radiation exposure
timeFrame: Up to 4 weeks
measure: Cost
timeFrame: Up to 4 weeks
measure: Restraint use
timeFrame: Up to 4 weeks
measure: Skin integrity
timeFrame: Up to 4 weeks
measure: Patient/Caregiver Satisfaction
timeFrame: Up to 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Childrens Hospital Colorado
name: Ashley Banks (Taubert-Dupey), BSN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.