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

Not Applicable

• Conditions: Urinary Tract Infections
• Interventions: Procedure: Pressure stimulus group

• Registration Number: NCT03152851
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

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

* 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 Timeline

• Study Start: 2016-11-01
• Study First Submitted: 2017-05-10
• Study First Submitted QC: 2017-05-11
• Study First Posted: 2017-05-15
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-16
• Last Update Posted: 2018-04-18
• Primary Completion: 2018-12-31
• Study Completion: 2019-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pressure stimulus group by ultrasound probe	Pressure stimulus group	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

Primary Outcome Measures

Name	Time	Method
The urine collection time	up to 2 hours	The urine collection time

Secondary Outcome Measures

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

Trial Locations

Locations (2)

The Seoul National Bundang Hospital; 🇰🇷 Seongnam, Gyeonggi-do, Korea, Republic of

Seoum national university; 🇰🇷 Seoul, Korea, Republic of