Ultrasound for Evaluation of Percutaneous G-tube Position

Gastrostomy Clinical Trial

Official title:

Accuracy of Ultrasound for the Evaluation of Percutaneous Gastrostomy Tube Position and Leakage

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06361498
• Other study ID #: 23-3115
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: March 2025

Study information

• Verified date: March 2024
• Source: University of North Carolina, Chapel Hill
• Contact: Hannah P Mignosa-Martin
• Phone: 9198431670
• Email: hannah_mignosa[@]med.unc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastrostomy

Intervention

Device:
• Ultrasound Imaging
Participant will receive ultrasound imaging to evaluate the replaced G-tube placement.

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion 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).	Upon completion of all study image data collection for all participants [approximately 1 year]
Secondary	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.	Upon completion of all study image data collection for all participants [approximately 1 year]
Secondary	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.	Upon completion of all study image data collection for all participants [approximately 1 year]
Secondary	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.	Upon completion of all study image data collection for all participants [approximately 1 year]