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
- 1
- 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
研究组 & 干预措施
Alaris Pump
Participants will receive IV fluids delivered by the Alaris IV Pump (standard of care) until their bladder is full.
LifeFlow
Participants will receive IV fluids delivered by the LifeFlow Fluid Device until their bladder is full.
干预措施: LifeFlow (Device)
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