Evaluation of a Novel Electronic Urine Output Monitor (eUOM)

Potrero Medical

Status: Completed

Conditions: Oliguria; Polyuria

Treatments: Device: Accuryn

Study type: Observational

Funder types: Industry

Identifiers

NCT02195713

PM-JMSRF2014-BCF01

Details and patient eligibility

About

Urine output and urine drain line pressure were monitored while urine was drained into either:

1. Accuryn Urine Output Monitor (Potrero Medical) OR
2. Criticore Monitor (Bard Medical)

Full description

The purpose of this study is to determine the characteristics of urine output and drain line pressure as measured with the Accuryn urinary output monitoring system and urine output as recorded by a commercially available system (Criticore, Bard Medical) when used with a standard Foley catheter and standard urinary drainage tube.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient must ≥ 18 years of age
• Patient has a Foley catheter and urine collection system is in place per standard clinical decision
• Estimated length of placement of the Foley is 48 hours minimum
• Burn injury ≥ 20% and ≤ 80% total body surface area (TBSA)
• Subject or subject's legally authorized representative is able to give informed consent before entering the study

Exclusion criteria

• Currently pregnant or breastfeeding
• Clinical signs or symptoms of a urinary tract infection (UTI)
• Clinical signs or symptoms of a vaginal infection
• Currently has bladder or urethral trauma
• Use of investigational drug/device therapy within the past 4 weeks

Trial design

20 participants in 2 patient groups

Test- Accuryn Urine Output Monitor

Description:

Accuryn Anti-airlock Drainage System was attached to the Foley catheter and urine output / drainage line pressure was monitored.

Treatment:

Device: Accuryn

Control- Critcore Urine Output Monitor

Description:

A commercially available urine output monitor (Criticore, Bard Medical) was attached to the Foley catheter and urine output / drainage line pressure was monitored.