Clinical trial NCT02751671: Point-of-care Ultrasound for Clean-Catch Urine Collection in Young Children
Official title: Are Stimulated Clean-Catch Urine Collection Techniques More Successful When Combined With Prior Emergency Point-of-care Ultrasound in Paediatric Patients?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinalysis
Children
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
First posted: 2016-04-26
Enrollment: 201
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Background:

The investigators recently evaluated a new bladder stimulation technique to obtain clean-catch urine in infants aged less than six months. In this study, the reported success rate was of 52%. Measuring the transversal bladder diameter prior to the procedure with emergency point-of-care ultrasound (ePOCUS) could likely increase success rates for this technique as it has been described for bladder scans prior to performing urethral catheterization.

Objective:

The aim of this study is to evaluate if using emergency point-of-care ultrasound to measure bladder volume improves clean-catch urine collection success in patients less than 6 months of age when compared to children undergoing this technique without a prior ultrasound.

Methods:

This will be a randomized controlled trial performed in a tertiary paediatric emergency department. Participants will include all infants younger than 6 months of age who need a urinary culture and/or analysis requested by the attending physician. The intervention will consist of the use of emergency point-of-care ultrasound by a trained research assistant. The primary outcome will be the rate of success of the procedure. Secondary objectives will be to evaluate time to collect urine samples and to determine which transversal bladder diameter correlates with more than a 90% success rate for the procedure. Independent variables will be sex and age. In both groups, trained research nurses will collect clean-catch urine samples using bladder stimulation techniques. The success rate of the CCU procedure in both groups will be calculated. The time required to collect urine samples will be analysed. In group 1, the investigators will determine the transversal bladder diameter corresponding to a success rate for the procedure of \> 80%. It is estimated that, in the worse-case scenario, the evaluation of 200 participants will provide a 95% confidence interval smaller than 10% for proportions. In addition, 20 participants with a successful CCU sample would allow to evaluate 2 risk factors using univariate and multivariate analysis.

Expected results:

This study will demonstrate that use of emergency point-of-care ultrasound increases success rates of stimulated clean-catch manoeuvres and may avoid invasive urethral catheterizations in young children.


Eligibility criteria: Inclusion Criteria:

* Children aged less than 6 months
* Urine sample ordered by the treating physician
* Presence of a research assistant

Exclusion Criteria:

* Any medical condition where obtaining a midstream urine sample is impossible (e.g. urostomy, anuria for 24h)
* Any serious illness or unstable infant (e.g. sepsis)
* Any medical situation where the infant cannot be fed (e.g NPO order, GCS\<15)
* Inability to obtain parental informed consent (language barrier, absence, etc.)

Primary outcomes:
measure: Successful clean-catch manoeuver
timeFrame: 5 minutes
Secondary outcomes:
measure: Delay for collection
timeFrame: 1 hour
measure: delay for procedure
timeFrame: 1 hour
measure: Nurse time
timeFrame: 2 hours
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: CHU Sainte-Justine
state: Quebec
Study officials:
References:
citation: Weill O, Labrosse M, Levy A, Desjardins MP, Trottier ED, Gravel J. Point-of-care ultrasound before attempting clean-catch urine collection in infants: a randomized controlled trial. CJEM. 2019 Sep;21(5):646-652. doi: 10.1017/cem.2019.30.