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Point-of-Care Ultrasound (POCUS) is a relatively quick and non-invasive technique to assess bladder fullness which will be provided under standard of care. The goal of this study is to assess for bladder fullness by measuring bladder volume using a handheld POCUS with AI technology to objectively determine patient readiness for pelvic ultrasound.
Nicklaus Children's Hospital's researches want to determine if the AI-POCUS assessment of bladder volume can shorten the time to transabdominal pelvic ultrasound. The primary objective is the time to transabdominal pelvic ultrasound (calculated from the time the ultrasound was ordered to when the ultrasound was started in Radiology). This information will be used to guide strategies for improvements in our care to patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AI Pocus | Experimental | Patients randomly assigned in a 1:1 ratio to receive usual care or the experimental AI-POCUS with bladder volume measurements |
|
| Standard transabdominal pelvic ultrasound | Active Comparator | Patients will follow the standard of care for ultrasound |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental AI POCUS | Other | Patients will be randomly assigned in a 1:1 ratio to receive usual care or the experimental AI-POCUS with bladder volume measurements every 30 minutes until the bladder is considered subjectively full or until 350-mL has been reached (whichever comes first). |
| Measure | Description | Time Frame |
|---|---|---|
| AI-POCUS assessment of bladder volume | This study aims to determine whether AI-POCUS assessment of bladder volume can expedite transabdominal pelvic ultrasound. The primary objective is time to transabdominal pelvic ultrasound (calculated from time the ultrasound was ordered to when the ultrasound was started in Radiology). | From enrollment to Pelvic Ultrasound |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Khalil, MD | Nicklaus Children's Hospital fka Miami Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nicklaus Children's Hospital | Miami | Florida | 33155 | United States |
Clinical Study Report
Starting 4-13-26, ending 4-13-28
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 4, 2026 | May 28, 2026 | 2 |
| ID | Term |
|---|---|
| D015746 | Abdominal Pain |
| D017699 | Pelvic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Standard of Care Ultrasound | Diagnostic Test | care group will be sent for pelvic ultrasound once they have endorsed a sensation of bladder fullness. |
|
| D012817 | Signs and Symptoms, Digestive |