Evaluation of a Novel Electronic Urine Output Monitor (eUOM)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-02-28

Brief Summary

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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

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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.

Conditions

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Oliguria Polyuria

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Test- Accuryn Urine Output Monitor

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

Accuryn

Intervention Type DEVICE

Accuryn is a novel electronic urine output monitor

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.

No interventions assigned to this group

Interventions

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Accuryn

Accuryn is a novel electronic urine output monitor

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No