Using ultrasound to check gastrostomy tube position
Accuracy of Ultrasound for the Evaluation of Percutaneous Gastrostomy Tube Position and Leakage
NA · University of North Carolina, Chapel Hill · NCT06361498
This study is testing if using ultrasound to check the position of gastrostomy tubes in kids is just as good and faster than the usual method called fluoroscopy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | University of North Carolina, Chapel Hill (other) |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT06361498 on ClinicalTrials.gov |
What this trial studies
This clinical trial compares the effectiveness of ultrasound imaging to fluoroscopy for assessing the position of gastrostomy tubes in pediatric patients who have recently undergone tube replacement. The study aims to determine if ultrasound is as accurate as fluoroscopy and whether it requires less time for evaluation. Participants will undergo ultrasound imaging prior to the standard fluoroscopic imaging to assess the position of the gastrostomy tube retention balloon and check for any potential leakage. The findings could lead to improved practices in clinical settings for monitoring gastrostomy tubes.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients with a dislodged gastrostomy tube who meet specific minor criteria related to recent tube placement or clinician uncertainty.
Not a fit: Patients over 18 years of age or those who are acutely ill and unstable will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a quicker and equally effective method for evaluating gastrostomy tube positions in children.
How similar studies have performed: While the use of ultrasound for various medical evaluations is established, this specific comparison with fluoroscopy in gastrostomy tube assessment is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Chapel Hill, North Carolina
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (RECRUITING)
Study contacts
- Principal investigator: William Pryor, MD — University of North Carolina, Chapel Hill
- Study coordinator: Hannah P Mignosa-Martin
- Email: hannah_mignosa@med.unc.edu
- Phone: 9198431670
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gastrostomy, gastrostomy tube, ultrasound, fluoroscopy