Point-of-care Ultrasound for Clean-Catch Urine Collection in Young Children

Children Clinical Trial

Official title:

Are Stimulated Clean-Catch Urine Collection Techniques More Successful When Combined With Prior Emergency Point-of-care Ultrasound in Paediatric Patients?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02751671
• Other study ID #: POCUS CCU
• Status: Completed
• Phase: N/A
• First received: April 21, 2016
• Last updated: August 1, 2017
• Start date: August 2016
• Est. completion date: June 2017

Study information

• Verified date: April 2017
• Source: St. Justine's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 5 Months

Eligibility

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.)

Related Conditions & MeSH terms

• Children
• Urinalysis

Intervention

Procedure:
• POCUS
The use of Point-of-care ultrasound before urine sample procedure
• Standard
Urine sampling procedure without prior ultrasound

Locations

Country	Name	City	State
Canada	CHU Sainte-Justine	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
St. Justine's Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful clean-catch manoeuver	The rate of successful clean-catch urine sample collection. Success is defined by the collection of a sample of urine of at least 2 mL, obtained within 300 seconds of bladder stimulation manoeuvers or obtained while disinfecting prior to the manoeuvre.	5 minutes
Secondary	Delay for collection	Time to collect urine sample from randomisation to sample collection	1 hour
Secondary	delay for procedure	Time to collect urine sample from beginning of stimulation to sample collection	1 hour
Secondary	Nurse time	Time that nurses have to spend with the patients	2 hours