Evaluation of a Novel Electronic Urine Output Monitor (eUOM)

Evaluation of a Novel Electronic Urine Output Monitor (eUOM)

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)

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.

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