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Completed

NCT Number: NCT03202576

Nasogastric Tube Securement Comparison Study

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nasal Bridle

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.

Other names: Microbridle

Primary outcomes

  1. Tube dislodgment

    Time frame: Up to 4 weeks

    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 outcomes

  1. Device usability

    Time frame: Up to 4 weeks

    Ease of use of the nasal bridle device

  2. Radiation exposure

    Time frame: Up to 4 weeks

    Number of X-rays to confirm tube placement.

  3. Cost

    Time frame: Up to 4 weeks

    Average costs among groups related to naso-gastric (NG) tube placement and replacement

  4. Restraint use

    Time frame: Up to 4 weeks

    Use of restraints for the purpose of tube protection.

  5. Skin integrity

    Time frame: Up to 4 weeks

    Skin integrity: complications/issues

  6. Patient/Caregiver Satisfaction

    Time frame: Up to 4 weeks

    Patient/caregiver satisfaction with bridle.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

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

Acronym: NTSNB

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jun 28, 2017
Registry last updated
Dec 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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