Ultrasound for Evaluation of Percutaneous G-tube Position

Not Applicable

Recruiting

• Conditions: Gastrostomy
• Interventions: Device: Ultrasound Imaging

• Registration Number: NCT06361498
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief 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.

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-22
• Study First Submitted QC: 2024-04-09
• Study First Posted: 2024-04-12
• Study Start: 2024-04-30
• Last Update Submitted: 2024-06-14
• Last Update Posted: 2024-06-18
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ultrasound Imaging	Ultrasound Imaging	This study consists of one group/ All participants will receive ultrasound imaging prior to the standard of care fluoroscopic imaging.

Primary Outcome Measures

Name	Time	Method
Proportion of Ultrasound that Agree with Fluoroscopy with Respect to Identifying the GT Location	Upon completion of all study image data collection for all participants [approximately 1 year]	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).

Secondary Outcome Measures

Name	Time	Method
Sensitivity of ultrasound (US) to determine the visualization of GT leakage	Upon completion of all study image data collection for all participants [approximately 1 year]	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.
Specificity of ultrasound (US) to determine the visualization of GT leakage	Upon completion of all study image data collection for all participants [approximately 1 year]	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.
Duration of ultrasound (US) to complete evaluation of GT position	Upon completion of all study image data collection for all participants [approximately 1 year]	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.

Trial Locations

Locations (1)

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States