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临床试验/NCT07535294
NCT07535294已完成不适用

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

Nicklaus Children's Hospital f/k/a Miami Children's Hospital1 个研究点 分布在 1 个国家目标入组 520 人开始时间: 2024年8月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
520
试验地点
1
主要终点
AI-POCUS assessment of bladder volume

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
8 Years 至 21 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

AI Pocus

Experimental

Patients randomly assigned in a 1:1 ratio to receive usual care or the experimental AI-POCUS with bladder volume measurements

干预措施: Experimental AI POCUS (Other)

Standard transabdominal pelvic ultrasound

Active Comparator

Patients will follow the standard of care for ultrasound

干预措施: Standard of Care Ultrasound (Diagnostic Test)

结局指标

主要结局

AI-POCUS assessment of bladder volume

时间窗: From enrollment to Pelvic Ultrasound

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).

次要结局

未报告次要终点

研究者

发起方
Nicklaus Children's Hospital f/k/a Miami Children's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Paul Khalil, M.D.

Principal Investigator

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

研究点 (1)

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