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Not Yet Recruiting 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07744945). StuddyBuddy aggregates publicly available trial information.