Skip to content

Assess Patient Readiness for Pelvic Ultrasound With the Use of Artificial Intelligence

Bladder Point-of-Care Ultrasound to Assess Patient Readiness for Pelvic Ultrasound With the Use of Artificial Intelligence

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07535294
Acronym
AI-POCUS
Enrollment
520
Registered
2026-04-17
Start date
2024-08-14
Completion date
2026-02-11
Last updated
2026-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Pain, Pelvic Pain

Keywords

abdominal pain, pelvic pain, AI POCUS, children

Brief summary

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.

Detailed description

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.

Interventions

OTHERExperimental AI POCUS

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).

DIAGNOSTIC_TESTStandard of Care Ultrasound

care group will be sent for pelvic ultrasound once they have endorsed a sensation of bladder fullness.

Sponsors

Nicklaus Children's Hospital f/k/a Miami Children's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
8 Years to 21 Years
Healthy volunteers
No

Inclusion criteria

* Females aged 8 - 21 years presenting to the Emergency Department with lower abdominal pain and with an order for a transabdominal pelvic ultrasound.

Exclusion criteria

* Patients less than 8 years or greater than 21 years * Males * Patients with a history of anatomical anomalies or known pregnancy * Patients that are critically ill, non-verbal or with significant developmental delay

Design outcomes

Primary

MeasureTime frameDescription
AI-POCUS assessment of bladder volumeFrom enrollment to Pelvic UltrasoundThis 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).

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORPaul Khalil, MD

Nicklaus Children's Hospital fka Miami Children's Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 25, 2026