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

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

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.

Study Overview

• Status: Unknown
• Conditions: Urinary Tract Infections
• Intervention / Treatment: Procedure: Pressure stimulus group

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

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoum national university
    • Contact: Jaeyoon Jung, Dr; Email: matewoos@gmail.com
  • Gyeonggi-do
    • Seongnam, Gyeonggi-do, Korea, Republic of, 13620
      • Recruiting
      • The Seoul National Bundang Hospital
      • Contact: YOOJIN CHOI, MD; Phone Number: 82-10-9360-9468; Email: choiyj0729@naver.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 2 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Procedure: Pressure stimulus group
No Intervention: Non-pressure stimulus group; No pressure stimulus would be given

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital
• Collaborators: Seoul National University Hospital
• Investigators: Principal Investigator: JAEYOON JUNG, MD PhD, The Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Anticipated): December 31, 2018
• Study Completion (Anticipated): March 31, 2019

Study Registration Dates

• First Submitted: May 10, 2017
• First Submitted That Met QC Criteria: May 11, 2017
• First Posted (Actual): May 15, 2017

Study Record Updates

• Last Update Posted (Actual): April 18, 2018
• Last Update Submitted That Met QC Criteria: April 16, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Urologic Diseases; Urinary Tract Infections
• Other Study ID Numbers: B-1609-362-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED