Evaluation of a Novel Electronic Urine Output Monitor (eUOM)

Oliguria Clinical Trial

Official title:

Evaluation of a Novel Electronic Urine Output Monitor (eUOM)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02195713
• Other study ID #: PM-JMSRF2014-BCF01
• Status: Completed
• Phase: N/A
• First received: July 15, 2014
• Last updated: January 20, 2016
• Start date: July 2014
• Est. completion date: February 2015

Study information

• Verified date: January 2016
• Source: Potrero Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Oliguria
• Polyuria

Intervention

Device:
• Accuryn
Accuryn is a novel electronic urine output monitor

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Potrero Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urine Output of SOC Device Versus Accuryn	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.	2 - 5 days	No

External Links

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