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Completed

NCT Number: NCT02751671

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

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.

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Key information

Conditions

Age range

Up to 5 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Sainte-Justine

Montreal, Quebec, H3T1C5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

POCUS

Procedure

The use of Point-of-care ultrasound before urine sample procedure

standard

Procedure

Urine sampling procedure without prior ultrasound

Primary outcomes

  1. Successful clean-catch manoeuver

    Time frame: 5 minutes

    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.

Secondary outcomes

  1. Delay for collection

    Time frame: 1 hour

    Time to collect urine sample from randomisation to sample collection

  2. delay for procedure

    Time frame: 1 hour

    Time to collect urine sample from beginning of stimulation to sample collection

  3. Nurse time

    Time frame: 2 hours

    Time that nurses have to spend with the patients

Sponsors and collaborators

Lead sponsor

St. Justine's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 26, 2016
Registry last updated
Aug 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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