The Utility of LifeFlow Rapid Fluid Infuser in Critical and Non-critical Pediatric Patients: a Mixed-method Pilot Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Duration- Ultrasound Ordered to Completed
研究概览
简要总结
This is an unblinded, randomized control study examining two fluid delivery modalities for non-critical female patients with a planned transabdominal pelvic ultrasound requiring intravenous fluid boluses.
详细描述
Subjects be identified during their clinical course in the ED and will be randomized to either the LifeFlow® fluid delivery or an IV fluid bolus through the Alaris® pump (standard of care). IV fluids will be provided until the subject notes the sensation of a full bladder, at which point, the standard of care clinical practice is to perform the ultrasound. The transabdominal pelvic ultrasound requires a full bladder for optimal visualization of the ovaries, adnexa, and uterus, and is the only alternative to a transvaginal pelvic ultrasound for virginal young women. All other clinical care is per standard of care. The only research component is the randomization and data collection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female patients older than 1 month and less than 18 years
- •Patients require IV crystalloid bolus fluids before a pelvic ultrasound
排除标准
- •Known cardiac insufficiency or significant cardiac surgery
- •Hepatic insufficiency
- •Renal insufficiency
- •Any known fluid overload states (ascites, pulmonary edema)
- •On any diuretic or antihypertensive therapy
- •Known pregnancy
结局指标
主要结局
Duration- Ultrasound Ordered to Completed
时间窗: From ED (Emergency Department) arrival to discharge/admission, less than 12 hours
The primary outcome variable is the duration (minutes) of time from when the ultrasound was ordered to the completion time of the ultrasound.
次要结局
- Total IV Fluid (mL)(From ED arrival to discharge/admission, less than 12 hours)
- Duration- Full Bladder(From ED arrival to discharge/admission, less than 12 hours)
研究者
Todd P Chang, MD MAcM
Principal Investigator
Children's Hospital Los Angeles