The Effect of Sonographic Bladder Compressive Technique for Bag Urine Collection in Pediatrics
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|ClinicalTrials.gov Identifier: NCT03152851|
Recruitment Status : Recruiting
First Posted : May 15, 2017
Last Update Posted : April 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Urinary Tract Infections||Procedure: Pressure stimulus group||Not Applicable|
- 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 (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Care Provider)|
|Official Title:||The Effect of Sonographic Bladder Compressive Stimulation Technique for Bag Urine Collection in Pediatrics: Randomized Controlled Trial|
|Actual Study Start Date :||November 1, 2016|
|Estimated Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||March 31, 2019|
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
- The urine collection time [ Time Frame: up to 2 hours ]The urine collection time
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03152851
|Contact: YOOJIN CHOI, MDemail@example.com|
|Korea, Republic of|
|The Seoul National Bundang Hospital||Recruiting|
|Seongnam, Gyeonggi-do, Korea, Republic of, 13620|
|Contact: YOOJIN CHOI, MD 82-10-9360-9468 firstname.lastname@example.org|
|Seoum national university||Recruiting|
|Seoul, Korea, Republic of|
|Contact: Jaeyoon Jung, Dr email@example.com|
|Principal Investigator:||JAEYOON JUNG, MD PhD||The Seoul National University Bundang Hospital|