Gastrostomy
Conditions
Keywords
gastrostomy tube, ultrasound, fluoroscopy
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.
Interventions
DEVICEUltrasound Imaging
Participant will receive ultrasound imaging to evaluate the replaced G-tube placement.
Sponsors
University of North Carolina, Chapel Hill
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTTracy Carroll
CONTACTDesma Jones
PRINCIPAL_INVESTIGATORWilliam Pryor, MD
University of North Carolina, Chapel Hill
Outcome results
None listed