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Evaluation of a Novel Electronic Urine Output Monitor (eUOM)

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ClinicalTrials.gov Identifier: NCT02195713
Recruitment Status : Completed
First Posted : July 21, 2014
Results First Posted : September 1, 2015
Last Update Posted : February 22, 2016
Sponsor:
Information provided by (Responsible Party):
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)

Condition or disease Intervention/treatment
Oliguria Polyuria Device: Accuryn

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.

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of a Novel Electronic Urine Output Monitor (eUOM)
Study Start Date : July 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
ICU patient that needs a Foley catheter
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02195713


Locations
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United States, Georgia
Joseph M. Still Burn Center at Doctors Hospital
Augusta, Georgia, United States, 30909
United States, Texas
The University of Texas Medical Branch (UTMBP)
Galveston, Texas, United States, 77555
Sponsors and Collaborators
Potrero Medical
Investigators
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Principal Investigator: George Kramer UTMB
Principal Investigator: Bruce Friedman Joseph M. Stills Burn Center
Additional Information:
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Responsible Party: Potrero Medical
ClinicalTrials.gov Identifier: NCT02195713    
Other Study ID Numbers: PM-JMSRF2014-BCF01
First Posted: July 21, 2014    Key Record Dates
Results First Posted: September 1, 2015
Last Update Posted: February 22, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Polyuria
Oliguria
Urination Disorders
Urologic Diseases
Urological Manifestations