Ultrasound for Evaluation of Percutaneous G-tube Position
ConditionGastrostomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorUniversity of North Carolina, Chapel Hill
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Surgical GT placement less than 90 days from presentation
Traumatic GT dislodgement/removal
Recent stoma dilation
Clinician uncertainty about position of GT placement
Disqualifiers
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
Design model
Single group
Treatments tested in this trial
Ultrasound Imaging
DeviceParticipant will receive ultrasound imaging to evaluate the replaced G-tube placement.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Ultrasound ImagingOther 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of Ultrasound that Agree with Fluoroscopy with Respect to Identifying the GT Location
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).
Time frame
Upon completion of all study image data collection for all participants [approximately 1 year]Secondary outcomes
1
Duration of ultrasound (US) to complete evaluation of GT position
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.
Time frame
Upon completion of all study image data collection for all participants [approximately 1 year]Sponsors and contacts
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Source ClinicalTrials.gov