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OpenTrials
Completed

NCT Number: NCT04621734

Retention of Nasoenteric Feeding Tubes in Pediatric Patients Using a Nasal Bridle

A study to compare tube dislodgment rates when a nasoenteric feeding tube is secured with adhesive tape vs the AMT BridlePro device.

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Key information

Conditions

Feeding Tube Complication

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Health System

San Antonio, Texas, 78229, United States

About this study

The adhesive tape will be the tape available in the unit and will be placed by the nurse or provider at the time of nasoenteric tube placement. The tape will be placed around the tube and secured to the cheek on the side of tube. The tape will be replaced as needed per nursing discretion when soiled or the adhesive properties are failing and this information will be tracked. The AMT BridlePro will be placed by the nurse or provider at the time of nasoenteric tube placement. Placement will use the BridlePro system included in the individual BridlePro packaging. Placement and securement will follow manufacturer recommendations and teaching. The BridlePro encircles the vomer bone of the nasal cavity to secure the tube. Sedation medication may be given per standard of care for nasoenteric tube placement at the discretion of the provider team but no separate or additional sedation medication will be given for securement with adhesive tape or the BridlePro.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Need for nasoenteric feeding
  • Admitted to University Hospital
  • Age 0-18 years

Exclusion criteria

  • Facial trauma
  • Nasal airway obstructions
  • Thrombocytopenia (<100 K/μL)
  • s/p septoplasty
  • Patients with vomer bone graft
  • Nasoenteric feeding tube placed and secured prior to being screened for study
  • Contraindication for the use of the BridlePro
  • Does not meet inclusion criteria

Treatment and study plan

AMT BridlePro Device

Device

A device used as an alternative securement method using the structure of the nasal cavity to secure the nasoenteric tube.

Other names: Applied Medical Technology (AMT) BridlePro Device

Adhesive Tape

Device

Adhesive tape used to secure nasoenteric tube

Other names: Tape

Primary outcomes

  1. Number of Tube Dislodgements Per 10 Tube Days.

    Time frame: 10 days

    The number of times the tube is dislodged for every 10 days of feeding tubes.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Registry information

Official study title

Improving Retention of Nasoenteric Feeding Tubes in Pediatric Patients Using a Nasal Bridle

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 9, 2020
Registry last updated
Aug 14, 2023

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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