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

Seoul National University

Status: Unknown

Conditions: Urinary Tract Infections

Treatments: Procedure: Pressure stimulus group

Study type: Interventional

Funder types: Other

Identifiers

NCT03152851

B-1609-362-001

Details and patient eligibility

About

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 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

Enrollment: 80 estimated patients

Sex: All

Ages: 3 to 35 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

80 participants in 2 patient groups

Pressure stimulus group by ultrasound probe

Experimental group

Description:

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

Treatment:

Procedure: Pressure stimulus group

Non-pressure stimulus group

No Intervention group

Description:

No pressure stimulus would be given