Evaluation of a Novel Electronic Urine Output Monitor (eUOM)

NCT02195713 — Completed, 20 participants, Potrero Medical

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Registry	NCT02195713
Status	Completed
Study type	Observational
Enrollment	20 (Actual)
Sponsor	Potrero Medical (Industry)
Conditions	Oliguria, Polyuria
Interventions	Accuryn (Device)
Dates	start 2014-07-01, primary completion 2015-02-01, completion 2015-02-01, first posted 2014-07-21, last updated 2016-02-22
Locations	2 sites in United States

-Summary

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)

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+Detailed 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.

+Arms and interventions

Arm	Type	Interventions	Description
Test- Accuryn Urine Output Monitor		Device: Accuryn	Accuryn Anti-airlock Drainage System was attached to the Foley catheter and urine output / drainage line pressure was monitored.
Control- Critcore Urine Output Monitor			A commercially available urine output monitor (Criticore, Bard Medical) was attached to the Foley catheter and urine output / drainage line pressure was monitored.

Accuryn (Device): Accuryn is a novel electronic urine output monitor

+Outcome measures

Primary outcomes

Urine Output of SOC Device Versus Accuryn [2 - 5 days]: Urine output as recorded by the SOC when connected to a standard Foley catheter and standard urinary drainage tube will be compared to urine output recorded by Accuryn and the SOC when connected to a standard Foley catheter and the Accuryn Drainage Tube.

+Eligibility

Sex: All, ages: 18 Years to any

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

+Posted results

Participant flow

Milestone	Test- Accuryn Urine Output Monitor	Control- Critcore Urine Output Monitor
Started	10	10
Completed	10	10
Not completed	0	0

Outcome results

Urine Output of SOC Device Versus Accuryn (Primary), Number, Patients with airlocks: Test- Accuryn Urine Output Monitor 0 (0 to 0); Control- Critcore Urine Output Monitor 5 (5 to 5)

Adverse events

Arm	Deaths	Serious adverse events	Other adverse events
Test- Accuryn Urine Output Monitor	0	0	0
Control- Critcore Urine Output Monitor	0	0	0

+Locations (2)

Facility	City	Country	Status
Joseph M. Still Burn Center at Doctors Hospital	Augusta, Georgia	United States
The University of Texas Medical Branch (UTMBP)	Galveston, Texas	United States

+Investigators

George Kramer, Principal investigator, UTMB
Bruce Friedman, Principal investigator, Joseph M. Stills Burn Center