The Effect of Sonographic Bladder Compressive Technique for Bag Urine Collection in Pediatrics

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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The Effect of Sonographic Bladder Compressive Stimulation Technique for Bag Urine Collection in Pediatrics: Randomized Controlled Trial

Conditions
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Urinary Tract Infections

Intervention / Treatment
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* Procedure: Pressure stimulus group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 35 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pressure stimulus group by ultrasound probe<br>A pressure stimulus would be applied once using a device (ultrasound probe) to the anteroposterior wall of the bladder until the anterior & posterior wall meet if the measured diameters (AP x T) is 2 X 2 or more by ultrasound | Procedure: Pressure stimulus group<br> <br> |
| No Intervention: Non-pressure stimulus group<br>No pressure stimulus would be given | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The urine collection time | The urine collection time | up to 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The antibiotic administration time | The antibiotic administration time | up to 1 day | 
| Emergency department(ED) length of stay time | Emergency department(ED) length of stay time | up to 1 day | 
| Comparison between the patients who were diagnosed as actual urinary tract infections and those who were not. | Comparison between the patients who were diagnosed as actual urinary tract | up to 1 day | 
| Complications | Complications | up to 1 month |