Oliguria, Polyuria
Conditions
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.
Interventions
DEVICEAccuryn
Accuryn is a novel electronic urine output monitor
Sponsors
Potrero Medical
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Test- Accuryn Urine Output Monitor Accuryn Anti-airlock Drainage System was attached to the Foley catheter and urine output / drainage line pressure was monitored.
Accuryn: Accuryn is a novel electronic urine output monitor | 9 |
| 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. | 9 |
| Total | 18 |
Baseline characteristics
| Characteristic | Test- Accuryn Urine Output Monitor | Control- Critcore Urine Output Monitor | Total |
|---|---|---|---|
| Age, Continuous | 44 years STANDARD_DEVIATION 22 | 52 years STANDARD_DEVIATION 17.9 | 49 years STANDARD_DEVIATION 20.2 |
| Region of Enrollment United States | 9 participants | 9 participants | 18 participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Male | 7 Participants | 8 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Urine Output of SOC Device Versus Accuryn
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.
Time frame: 2 - 5 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test- Accuryn Urine Output Monitor | Urine Output of SOC Device Versus Accuryn | 0 Patients with airlocks |
| Control- Critcore Urine Output Monitor | Urine Output of SOC Device Versus Accuryn | 5 Patients with airlocks |