Ultrasound for Evaluation of Percutaneous G-tube Position

University of North Carolina (UNC)

Status: Enrolling

Conditions: Gastrostomy

Treatments: Device: Ultrasound Imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT06361498

23-3115

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Ultrasound Imaging

Other group

Description:

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

Treatment:

Device: Ultrasound Imaging