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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-01

Study Completion Date

2019-03-31

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.

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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

Conditions

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Urinary Tract Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Caregivers

Study Groups

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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

Group Type EXPERIMENTAL

Pressure stimulus group

Intervention Type PROCEDURE

Non-pressure stimulus group

No pressure stimulus would be given

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Pressure stimulus group

Intervention Type PROCEDURE

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

Minimum Eligible Age

3 Months

Maximum Eligible Age

35 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes