NCT03152851Unknown不适用
The Effect of Sonographic Bladder Compressive Stimulation Technique for Bag Urine Collection in Pediatrics: Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- The urine collection time
研究概览
简要总结
Aim: to shorten the time of urination by bladder pressure stimulation in children less than 36 months of age who need urinalysis to exclude or diagnose urinary tract infections and to speed up the start time of antibiotics treatment or to eliminate the overcrowding of emergency room(ER) by shortening the time of ER stay.
详细描述
- According to preassigned 1:1 randomization of 40 patients assigend to intervention group and other 40 patients assign to control group as follow.
- Get documented agreement from the caregiver if the patient meets the criteria.
- While the a nurse attaches a kismo to a patient, the researcher at the bedside measures the patient's bladder size as an maximal anteroposterior (AP) and transverse (T) diameter(cm)
- If the measured diameters (AP x T) is 2 X 2 or more, the research assistant check the assigned group of the patient.
- If the patient assigned to the intervention group, a pressure stimulus is applied once using an ultrasonic probe to the anteroposterior wall of the bladder until the anterior & posterior wall meet.
- If the AP X T was less than 2 X 2, excluded from the study enrollment.
- During the study, caregivers and the assigned nurse will be blinded
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 3 Months 至 35 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body temperature of patients ≥ 38℃ reported by guardians
- •No definite focus of fever detected by physical examination
- •Guardian agrees to use urine bag(kismo) collection technique
排除标准
- •Previous history of urinary tract infections
- •Underlying urinary tract diseases (eg congenital anomalies, neuroblastomas, already diagnosed bladder ureters)
- •ICU treatment indicated
- •Newly diagnosed hydronephrosis on the day of visit
结局指标
主要结局
The urine collection time
时间窗: up to 2 hours
The urine collection time
次要结局
- Complications(up to 1 month)
- Comparison between the patients who were diagnosed as actual urinary tract infections and those who were not.(up to 1 day)
- The antibiotic administration time(up to 1 day)
- Emergency department(ED) length of stay time(up to 1 day)
研究者
Hyuksool Kwon
Clinical assistant Professor
Seoul National University Bundang Hospital
研究点 (4)
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