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Nasogastric Tube Securement Comparison Study (NTSNB)

Primary Purpose

Failure to Thrive, Nutritional Deficiency, Constipation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nasal Bridle
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Failure to Thrive focused on measuring nasogastric tube, microbridle

Eligibility Criteria

1 Day - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Nasogastric tube standard securement

    Nasogastric Tube Nasal Bridle Securement

    Arm Description

    Standard securement of nasogastric tube with adhesive tape

    Securement of NG with AMT Micro Bridle

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

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

    Full Information

    First Posted
    June 12, 2017
    Last Updated
    December 15, 2020
    Sponsor
    University of Colorado, Denver
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03202576
    Brief Title
    Nasogastric Tube Securement Comparison Study
    Acronym
    NTSNB
    Official Title
    Nasogastric Tube Securement: Comparison of Standard Practice Versus Nasal Bridle for Pediatric Hospitalized Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    October 1, 2016 (Actual)
    Primary Completion Date
    March 31, 2020 (Actual)
    Study Completion Date
    August 20, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Colorado, Denver

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Failure to Thrive, Nutritional Deficiency, Constipation, Bowel Obstruction, Feeding and Eating Disorders
    Keywords
    nasogastric tube, microbridle

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Evaluate the securement of the Nasogastric tube either by standard securement or using a Nasal Bridal securement method.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    43 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Nasogastric tube standard securement
    Arm Type
    No Intervention
    Arm Description
    Standard securement of nasogastric tube with adhesive tape
    Arm Title
    Nasogastric Tube Nasal Bridle Securement
    Arm Type
    Experimental
    Arm Description
    Securement of NG with AMT Micro Bridle
    Intervention Type
    Device
    Intervention Name(s)
    Nasal Bridle
    Other Intervention Name(s)
    Microbridle
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Tube dislodgment
    Description
    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 Outcome Measure Information:
    Title
    Device usability
    Description
    Ease of use of the nasal bridle device
    Time Frame
    Up to 4 weeks
    Title
    Radiation exposure
    Description
    Number of X-rays to confirm tube placement.
    Time Frame
    Up to 4 weeks
    Title
    Cost
    Description
    Average costs among groups related to naso-gastric (NG) tube placement and replacement
    Time Frame
    Up to 4 weeks
    Title
    Restraint use
    Description
    Use of restraints for the purpose of tube protection.
    Time Frame
    Up to 4 weeks
    Title
    Skin integrity
    Description
    Skin integrity: complications/issues
    Time Frame
    Up to 4 weeks
    Title
    Patient/Caregiver Satisfaction
    Description
    Patient/caregiver satisfaction with bridle.
    Time Frame
    Up to 4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Day
    Maximum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. 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. Exclusion Criteria: 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ashley Banks (Taubert-Dupey), BSN
    Organizational Affiliation
    Childrens Hospital Colorado
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    25606648
    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.
    Results Reference
    result
    PubMed Identifier
    24440003
    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.
    Results Reference
    result
    PubMed Identifier
    18827069
    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.
    Results Reference
    result
    PubMed Identifier
    23455863
    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.
    Results Reference
    result

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