N/A
N=20
Evaluation of a Novel Electronic Urine Output Monitor (eUOM)
Oliguria · Polyuria
Bottom Line
View on ClinicalTrials.gov: NCT02195713 ↗Enrolled (actual)
20
Serious AEs
—
Results posted
Sep 2015
Primary outcome: Primary: Urine Output of SOC Device Versus Accuryn — 0; 5 Patients with airlocks
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Accuryn (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Potrero Medical
- Primary completion
- Feb 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Urine Output of SOC Device Versus Accuryn |
0; 5 | — |
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)
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02195713). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.