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

NCT ID: NCT02751671

Last Updated: 2017-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 201 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2017-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

POCUS before clean catch sampling

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.

Group Type: EXPERIMENTAL

POCUS

Intervention Type: PROCEDURE

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

Standard clean catch sampling

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

Group Type: EXPERIMENTAL

Standard

Intervention Type: PROCEDURE

Urine sampling procedure without prior ultrasound

Interventions

POCUS

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

Intervention Type: PROCEDURE

Standard

Urine sampling procedure without prior ultrasound

Intervention Type: PROCEDURE

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.)

• Maximum Eligible Age: 5 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Justine's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jocelyn Gravel

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

CHU Sainte-Justine

Montreal, Quebec, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 31006399 (View on PubMed)

Other Identifiers

POCUS CCU

Identifier Type: -

Identifier Source: org_study_id