ICU Patients, Urine Output
Conditions
Brief summary
The goal of this observational pilot study is to learn about the ability of the PureWick® Flex Female External Catheter and the PureWIck® Male External Catheter to capture urine output in adult ICU patients compared to indwelling urinary catheters. The study will also gather feedback from ICU clinicians about the suitability of PureWick® urine output data to inform clinical decision-making.
Interventions
A thin, flexible, sterile tube that is inserted through the urethra into the bladder to drain urine, typically into a urine meter
DEVICEExternal Urinary Catheter
A non-sterile, external catheter intended for non-invasive urine output management
Sponsors
C. R. Bard
Becton, Dickinson and Company
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult patients =18 years at the time of ICU admission 2. Female and Male Patients requiring urine output monitoring 3. Provision of a signed and dated informed consent form
Exclusion criteria
1. Frequent episodes of bowel incontinence without a fecal management system in place; or 2. Has moderate to heavy menstruation or vaginal bleeding and cannot use a tampon or menstrual cup; or 3. Has urinary retention; or 4. Is agitated, combative, restless, and/or uncooperative and may remove or dislodge the external catheter or indwelling catheter; or 5. Presence of moderate to severe insensible fluid loss, including but not limited to: Diaphoresis; Anasarca; or, based on the investigator's assessment, is unlikely to provide accurate urine leakage measurements on the pad due to the presence of other fluids (e.g. blood, stool); or 6. Any other condition that, in the opinion of the investigator, would preclude them from participating in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urine Capture Rate | Approximately every 4 hours for up to 72 hours | Capture rate is calculated as the weight of captured urine (post-void graduated cylinder weight - pre-void graduated cylinder weight) / total urine volume (captured urine + leaked urine (post-void absorbent pad weight - pre-void absorbent pad weight) \* 100 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ICU Clinician Acceptability | From start of the observation period to the end of the observation period, up to 72 hours | A survey completed by ICU clinicians to assess the suitability of using urine output measurement data to inform clinical decision making on a 4-point Likert scale with lower scores indicating a better outcome. |
Countries
United States
Contacts
CONTACTJosh Hobson
CONTACTKirsten Hammitt
Outcome results
None listed