NCT07744945尚未招募不适用
A Prospective, Observational Pilot Study Evaluating the Performance and Clinical Acceptance of PureWick® When Used in the ICU for Urine Output Monitoring
C. R. Bard1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2026年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Urine Capture Rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients =18 years at the time of ICU admission
- •Female and Male Patients requiring urine output monitoring
- •Provision of a signed and dated informed consent form
排除标准
- •Frequent episodes of bowel incontinence without a fecal management system in place; or
- •Has moderate to heavy menstruation or vaginal bleeding and cannot use a tampon or menstrual cup; or
- •Has urinary retention; or
- •Is agitated, combative, restless, and/or uncooperative and may remove or dislodge the external catheter or indwelling catheter; or
- •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
- •Any other condition that, in the opinion of the investigator, would preclude them from participating in the study
结局指标
主要结局
Urine Capture Rate
时间窗: 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
次要结局
- ICU Clinician Acceptability(From start of the observation period to the end of the observation period, up to 72 hours)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
2 期
A clinical study on Perimenopause symptoms.CTRI/2025/04/084887Gplife Healthcare Pvt Ltd60
招募中
4 期
Safer Kidney Stone Surgery Using New Flexible Tubes: A Study with Indian PatientsCTRI/2025/07/091760Sri Ramachandra institute of Higher education and Research300
招募中
2 期
PKB171 Against Placebo in Couples With Mild Male Factor InfertilityInfertility Due to AzoospermiaNCT07669584Prokrea BCN, S.L.732
招募中
不适用
Safety and Efficacy Assessment for the Temporary Facial Skin Tightening Improvement Effect Using the Monopolar Radiofrequency DeviceNCT07471399CLASSYS Inc.96
尚未招募
不适用
A Randomised Controlled Trial of ePROM-Guided Flexible Scheduling in DermatologyUrticariaAcneNCT07481019National University Hospital, Singapore250