Gravity of Flow: Automating Diuresis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Accuracy of urine output measurement using the FlowSure automated monitoring device compared with manual monitoring
研究概览
简要总结
The goal of this randomized clinical trial is to evaluate the accuracy of automated urine output monitoring using the FlowSure system compared to standard manual urine monitoring in hospitalized patients with an indwelling urinary catheter.
The main questions it aims to answer are:
How accurate is the automated FlowSure monitoring compared with manual urine monitoring over defined time intervals (8-hour nursing shifts and 24-hour periods)?
Does the automated system improve completeness of hourly urine output registration compared with manual documentation?
Researchers will compare patients monitored with the automated FlowSure device to those monitored using the manual method to determine whether automation provides more accurate and complete diuresis data.
Participants will:
Be adult patients admitted to the hospital with a urinary catheter inserted for routine medical reasons (not related to this study).
In Part B, be randomized to either manual urine monitoring or automated FlowSure monitoring for defined time intervals.
There is no direct benefit to participants. The potential societal benefit lies in improving the accuracy, efficiency, and safety of diuresis monitoring through automation. The risks are minimal and limited to use of the FlowSure device in addition to, or instead of, standard monitoring; no additional procedures are performed.
详细描述
Accurate monitoring of urine output is essential in the management of hospitalized patients, particularly those with hemodynamic instability or fluid balance disorders. Currently, diuresis monitoring is performed manually by nursing staff, which is labor intensive and prone to transcription or timing errors. The FlowSure system is an automated urine output monitoring device designed to continuously measure and record urine production and transfer these data directly to the electronic medical record (EMR). Automation may improve data quality, reduce nursing workload, and enhance patient safety.
This study consists of two parts. Part A is a technical feasibility study in which patients are simultaneously monitored using both manual and automated FlowSure systems to evaluate concordance between the two methods under real-world conditions. Part B is a two-arm randomized, non-blinded intervention study comparing automated versus manual urine output monitoring. Patients will be randomized in a 1:1 ratio to either standard manual monitoring or automated FlowSure monitoring. Randomization occurs after insertion of a urinary catheter, which is placed for medical reasons unrelated to the study.
The primary objective of Part B is to assess the accuracy of urine production measurement by the automated FlowSure monitor compared with manual monitoring over two time frames: (1) an 8-hour nursing shift and (2) a full 24-hour period. The primary endpoint is the completeness and accuracy of hourly diuresis registration between the two monitoring methods. Secondary analyses will include evaluation of data recording efficiency and the rate of missing or incorrect entries in the EMR.
There is no direct therapeutic benefit to participants. The anticipated scientific and societal benefit lies in improving the reliability and efficiency of diuresis monitoring, potentially enhancing patient care and reducing nursing workload. The risks associated with participation are minimal. In Part A, the automated monitor operates in addition to the manual system; in Part B, patients are monitored using only one method. In case of device malfunction or data loss, urine output can be estimated from total collected volume over time. Given the low risk profile and the potential to improve clinical monitoring practices, the overall risk-benefit balance of the study is considered favorable.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
Open-label study; care providers and investigators are aware of group assignment. Data analysis is based on objective device measurements.
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
- •Age 18 years or older.
- •Currently hospitalized.
- •Indwelling urinary catheter inserted for medical reasons unrelated to the study.
- •Able and willing to provide written informed consent.
- •No specific urological problems.
排除标准
- •No urinary catheter in place.
- •Diuresis < 30 mL per hour at screening.
研究组 & 干预措施
Manual Urine Monitoring
Participants in this arm will be monitored using the standard manual urine measurement system consisting of a measuring chamber and urine collection bag. Nursing staff will manually record hourly urine output in the electronic medical record according to routine hospital procedures.
干预措施: Manual Urine Monitoring System (Device)
Automated Monitoring
Participants in this arm will be monitored using the investigational automated urine output monitoring device. The device continuously weighs the urine collection bag to calculate urine volume in milliliters per hour and automatically transfers data to the electronic medical record.
干预措施: FlowSure Automated Urine Output Monitor (Device)
结局指标
主要结局
Accuracy of urine output measurement using the FlowSure automated monitoring device compared with manual monitoring
时间窗: Over a single 8-hour nursing shift and a full 24-hour monitoring period
Accuracy will be defined as the agreement between urine output measured by the FlowSure device and manual measurement (reference standard) over predefined time intervals of 8 hours and 24 hours.
次要结局
- Completeness of hourly urine output registration in the electronic medical record(Over a single 8-hour nursing shift and a full 24-hour monitoring period)
研究者
R.E. Knops
Professor, MD
Amsterdam Universitair Medische Centra