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

Nicklaus Children's Hospital f/k/a Miami Children's Hospital520 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

520

Conditions

Abdominal Pain Pelvic Pain

Interventions

Experimental AI POCUSOTHER

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).

Standard of Care UltrasoundDIAGNOSTIC_TEST

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

Eligibility

Sex: FEMALEMin age: 8 YearsMax age: 21 Years

Medical Language ↔ Plain English

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

Locations (1)

Nicklaus Children's Hospital

Miami, Florida, United States

Outcomes

Primary Outcomes

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).

Time frame: From enrollment to Pelvic Ultrasound

Data from ClinicalTrials.gov

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