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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
10
Participant will receive ultrasound imaging to evaluate the replaced G-tube placement.
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
RECRUITINGProportion of Ultrasound that Agree with Fluoroscopy with Respect to Identifying the GT Location
Proportional accuracy of ultrasound in identifying the gastrostomy tube (GT) balloon location based on the readers' (radiologists) ability to use the ultrasound to locate the GT balloon in comparison with the gold standard (fluoroscopic tube injection).
Time frame: Upon completion of all study image data collection for all participants [approximately 1 year]
Sensitivity of ultrasound (US) to determine the visualization of GT leakage
Sensitivity of ultrasound to determine the visualization of the GT leakage is defined as the ability of readers (radiologists) to use the ultrasound to determine the presence or absence of injected saline leakage under ultrasound using fluoroscopic tube injection as the gold standard.
Time frame: Upon completion of all study image data collection for all participants [approximately 1 year]
Specificity of ultrasound (US) to determine the visualization of GT leakage
Specificity of ultrasound to determine the visualization of the GT leakage is defined as the ability of readers (radiologists) to use the ultrasound to determine the presence or absence of injected saline leakage under ultrasound using fluoroscopic tube injection as the gold standard.
Time frame: Upon completion of all study image data collection for all participants [approximately 1 year]
Duration of ultrasound (US) to complete evaluation of GT position
Duration of ultrasound to complete the evaluation of the GT position is defined as the length of time necessary to complete a research US evaluation of the GT position using fluoroscopic tube injection as the gold standard.
Time frame: Upon completion of all study image data collection for all participants [approximately 1 year]
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