Evaluation of a Novel Electronic Urine Output Monitor (eUOM)

January 20, 2016 updated by: Potrero Medical

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Joseph M. Still Burn Center at Doctors Hospital
    • Texas
      • Galveston, Texas, United States, 77555
        • The University of Texas Medical Branch (UTMBP)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

ICU patient that needs a Foley catheter

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urine Output of SOC Device Versus Accuryn
Time Frame: 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.
2 - 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Potrero Medical

Investigators

  • Principal Investigator: George Kramer, UTMB
  • Principal Investigator: Bruce Friedman, Joseph M. Stills Burn Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (ACTUAL)

February 1, 2015

Study Completion (ACTUAL)

February 1, 2015

Study Registration Dates

First Submitted

July 15, 2014

First Submitted That Met QC Criteria

July 16, 2014

First Posted (ESTIMATE)

July 21, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

February 22, 2016

Last Update Submitted That Met QC Criteria

January 20, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PM-JMSRF2014-BCF01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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