Clinical trial NCT06361498: Ultrasound for Evaluation of Percutaneous G-tube Position
Official title: Accuracy of Ultrasound for the Evaluation of Percutaneous Gastrostomy Tube Position and Leakage
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastrostomy
Keywords: gastrostomy tube
ultrasound
fluoroscopy
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2024-04-12
Enrollment: 10
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of Ultrasound that Agree with Fluoroscopy with Respect to Identifying the GT Location
timeFrame: Upon completion of all study image data collection for all participants [approximately 1 year]
Secondary outcomes:
measure: Sensitivity of ultrasound (US) to determine the visualization of GT leakage
timeFrame: Upon completion of all study image data collection for all participants [approximately 1 year]
measure: Specificity of ultrasound (US) to determine the visualization of GT leakage
timeFrame: Upon completion of all study image data collection for all participants [approximately 1 year]
measure: Duration of ultrasound (US) to complete evaluation of GT position
timeFrame: Upon completion of all study image data collection for all participants [approximately 1 year]
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: William Pryor, MD
role: PRINCIPAL_INVESTIGATOR
References: