Evaluation of a Novel Electronic Urine Output Monitor (eUOM)

Completed

• Conditions: Polyuria; Oliguria
• Interventions: Device: Accuryn

• Registration Number: NCT02195713
• Lead Sponsor: Potrero Medical

Brief 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)

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.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-15
• Study First Submitted QC: 2014-07-16
• Study First Posted: 2014-07-21
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Results First Submitted: 2015-08-03
• Results First Submitted QC: 2015-08-03
• Results First Posted: 2015-09-01
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-20
• Last Update Posted: 2016-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Test- Accuryn Urine Output Monitor	Accuryn	Accuryn Anti-airlock Drainage System was attached to the Foley catheter and urine output / drainage line pressure was monitored.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Joseph M. Still Burn Center at Doctors Hospital; 🇺🇸 Augusta, Georgia, United States

The University of Texas Medical Branch (UTMBP); 🇺🇸 Galveston, Texas, United States