Ultrasound for Evaluation of Percutaneous G-tube Position
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ultrasound Imaging.
- Who it may be relevant to
- Registry conditions: Gastrostomy. Basic parameters: up to 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Accuracy of Ultrasound for the Evaluation of Percutaneous Gastrostomy Tube Position and Leakage
Overview
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.
Interventions
- Device Ultrasound Imaging
Participant will receive ultrasound imaging to evaluate the replaced G-tube placement.
Primary outcome measures
- Proportion of Ultrasound that Agree with Fluoroscopy with Respect to Identifying the GT Location [Time frame: Upon completion of all study image data collection for all participants [approximately 1 year]]
Secondary outcome measures (1)
- Duration of ultrasound (US) to complete evaluation of GT position [Time frame: Upon completion of all study image data collection for all participants [approximately 1 year]]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- University of North Carolina at Chapel Hill — Chapel Hill
Identifiers
NCT: NCT06361498 · 23-3115