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

NCT02751671 | Completed

• 1 other identifier: POCUS CCU
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinalysis; Children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Delay for collection

  1 hour

• delay for procedure

  1 hour

• Nurse time

  2 hours

Study Arms (2)

POCUS before clean catch sampling

EXPERIMENTAL

The intervention of interest will be the use of emergency point-of-care ultrasound performed by a research assistant to evaluate bladder fullness before clean-catch stimulation manoeuvre. More specifically, following randomisation, children in the experimental group will have ePOCUS to measure the transversal bladder diameter. If the transversal bladder diameter is \> 2 cm, the CCU procedure will be started without a prior feeding period. If the diameter is \< 2 cm, the CCU will be postponed for a 20 minute feeding period and a new ePOCUS will be done. After the second ePOCUS, the CCU will be done if the transversal bladder diameter reaches \> 2cm. If not, the child will have another 20 minute feeding period and a third ePOCUS prior to proceeding to the CCU regardless the bladder diameter.

Procedure: POCUS

Standard clean catch sampling

EXPERIMENTAL

Patients allocated to this arm will have a 20 minute feeding period either being breastfed or provided with formula intake appropriate to the infant's age and weight. If possible, the genital areas of the infant will be cleaned with warm water and soap and dried with sterile gauze prior to the feeding. The parents will let the diaper opened and will be will be ready to collect urine if the child voids during the feeding period. After the feeding, the stimulated clean-catch procedure will be performed without prior ultrasound

Procedure: Standard

Interventions

POCUS PROCEDURE

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

POCUS before clean catch sampling

Standard PROCEDURE

Urine sampling procedure without prior ultrasound

Standard clean catch sampling

Eligibility Criteria

• Age: Up to 5 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• St. Justine's Hospital: lead

Study Sites (1)

CHU Sainte-Justine

Montreal, Quebec, H3T1C5, Canada

Location

Related Publications (1)

• 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.

  PMID: 31006399 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 21, 2016
• First Posted: April 26, 2016
• Study Start: August 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: August 3, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)