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

Overview

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.

Full Title of Study: “The Effect of Sonographic Bladder Compressive Stimulation Technique for Bag Urine Collection in Pediatrics: Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: Single (Care Provider)
  • Study Primary Completion Date: December 31, 2018

Detailed Description

– 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

Interventions

  • Procedure: Pressure stimulus group

Arms, Groups and Cohorts

  • Experimental: Pressure stimulus group by ultrasound probe
    • 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
  • No Intervention: Non-pressure stimulus group
    • No pressure stimulus would be given

Clinical Trial Outcome Measures

Primary Measures

  • The urine collection time
    • Time Frame: up to 2 hours
    • The urine collection time

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 3 Months

Maximum Age: 35 Months

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Seoul National University Bundang Hospital
  • Collaborator
    • Seoul National University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Hyuksool Kwon, Clinical assistant Professor – Seoul National University Bundang Hospital
  • Overall Official(s)
    • JAEYOON JUNG, MD PhD, Principal Investigator, The Seoul National University Bundang Hospital
  • Overall Contact(s)
    • YOOJIN CHOI, MD, 82-10-9360-9468, choiyj0729@naver.com

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