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OpenTrials
Completed

NCT Number: NCT02195713

Evaluation of a Novel Electronic Urine Output Monitor (eUOM)

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)

Completed

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Key information

Conditions

Oliguria Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Polyuria Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Accuryn

Device

Accuryn is a novel electronic urine output monitor

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Potrero Medical

Industry

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 21, 2014
Registry last updated
Feb 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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