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NCT06361498NARecruiting

Ultrasound for Evaluation of Percutaneous G-tube Position

University of North Carolina, Chapel Hill

Start Date

4/30/2024

Completion Date

6/1/2027

Summary

The goal of this clinical trial is to compare using ultrasound imaging to look at the position of the gastrostomy tube (GT) against fluoroscopic imaging in pediatric patients who had a recent GT tube replacement. The main questions it aims to answer are: * If ultrasound is just as accurate as fluoroscopy to assess the GT position. * If ultrasound takes less time than fluoroscopy to assessing the GT position. Participants will be imaging using ultrasound to assess GT positioning before their standard of care fluoroscopic imaging.

Detailed Description

This clinical trial will address the validity of using ultrasound to evaluate the position of the gastrostomy tube (GT) retention balloon against the clinical gold standard of fluoroscopic tube injection to assess for potential larger studies and the implementation in clinical practice. This study will address the ability to visualize the retention balloon within the gastric lumen, the ability to assess for leakage from the GT within the abdomen, and the relative length of each study to perform.

Eligibility Criteria

Age Range: No minimum to 18 years

Inclusion Criteria: An individual who presents with a dislodged GT and meets one of the following minor criteria: * Surgical GT placement less than 90 days from presentation * Traumatic GT dislodgement/removal * Recent stoma dilation * Clinician uncertainty about position of GT placement Exclusion Criteria: * An individual \>18 years of age * Acutely ill patients defined as hemodynamically unstable defined as any child who has abnormal vital signs or disruption of vital functions (i.e. airway, breathing, circulation, mental function). Vital signs are based on patient age. Initial assessment of clinical patient stability will be provided by the ordering/referring provider.

Interventions

DEVICE

Ultrasound Imaging

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Conditions

Gastrostomy

Locations

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina 27599

United States