BULLET: Bladder Ultrasound Limits Length (of Time), Expedites Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Time to Successful Completion of Pelvic Ultrasound
研究概览
简要总结
In this study patients presenting to the pediatric ER with abdominal or pelvic complaints will be randomized to urethral bladder catheter or bladder ultrasound to compare time to completion of successful pelvic ultrasound, as determined by full visualization of uterus and ovaries.
详细描述
In this study, we will enroll female pediatric emergency department (ED) patients presenting with a diagnosis of abdominal pain who may have a transabdominal pelvic ultrasound ordered by their treating physician (or nurse practitioner). In order to maximize the visualization of organs deep within the pelvis such as the ovaries and uterus, the patient's bladder must be full. The current practice at our institution, as well as numerous others, is to have a bladder catheter placed immediately when a transabdominal pelvic ultrasound is ordered, and then to fill the bladder in a retrograde manner in order to provide enhanced visualization of the pelvic structures. The process of inserting a bladder catheter into a pediatric patient is an invasive procedure which can be traumatic and painful to the patient. Additionally, if the patient's bladder is already full, this procedure may be unnecessary.
In this study, a point-of-care bladder ultrasound will be performed, upon enrollment of a patient by a study bedside sonographer (our pediatric emergency department nurse practitioners), to assess degree of bladder fullness. This measurement will then be repeated serially while the patient is receiving hydration and the ultrasound will be performed when the bladder is full. We hypothesize that this work flow will result in an equivalent time to transabdominal pelvic ultrasound completion and will reduce the number of potentially traumatic and painful, invasive urethral bladder catheterizations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 18 Years(Child, Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 8yr-18yrs
- •Likely to have order placed for transabdominal pelvic ultrasound/ovarian ultrasound
- •No history of pelvic or bladder reconstructive surgery
排除标准
- •Pregnancy (known)
- •Critically ill patients
- •Patients with known renal or genitourinary structural abnormalities or prior pelvic/genitourinary surgery
- •Chronic renal disease
- •Patients presenting outside the defined treatment windows
结局指标
主要结局
Time to Successful Completion of Pelvic Ultrasound
时间窗: Baseline to 180 minutes
Time zero (order placed) to time completed (time pelvic ultrasound images are completed)
次要结局
- Pain of Bladder Ultrasound vs. Pain of Bladder Catheter as Measured by Verbal Numerical Rating Scale (VNRS)(When bladder ultrasound performed OR when urinary catheter placed to time of completion of pelvic ultrasound, up to 180 minutes)
研究者
Stephen Ruffenach
Principal Investigator
University of Alabama at Birmingham
