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NCT07744945
Evaluation of Male and Female External Catheters for Urine Output Monitoring in the ICU
Conditions: Urine Output, ICU Patients
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 32
Sponsor: C. R. Bard
Location: Intermountain Medical Center Murray Utah
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07744945). StuddyBuddy aggregates publicly available trial information.