Automated Fluid Output Tracking Device for Monitoring Hospital Patients

Overseen By Amy Bush

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Stoma, Catheter, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

54 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine whether a prototype toilet device that we have developed can accurately and automatically track human fluid output from renal and gastrointestinal systems in the hospital. The device includes components that can be outfitted onto existing toilets. In this study, participants hospital room will be outfitted with the prototype toilet device. Participants will use the toilet as usual throughout the duration of their inpatient stay. Sometimes output will be measured by the device, and other times output will be measured manually by nurses.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on monitoring fluid output, so it's unlikely that your medications will need to be changed, but please confirm with the trial coordinators.

What data supports the effectiveness of the treatment Automated Fluid Output Tracking Device for Monitoring Hospital Patients?

Research shows that smart toilet systems can effectively monitor health by analyzing urine and stool, similar to how the Automated Fluid Output Tracking Device might work. Additionally, automated systems like PleurAlert and other urine monitoring devices have been shown to reduce workload for healthcare staff and improve accuracy in monitoring fluid output, suggesting potential benefits for hospital patients. ^{1 2 3 4 5}

Is the Automated Fluid Output Tracking Device safe for use in humans?

Research on similar devices, like intelligent toilets and urine monitoring systems, suggests they are generally safe for human use. These devices are designed to be simple and unobtrusive, focusing on monitoring health without causing harm. ^{3 6 7 8 9}

How does the automated fluid output tracking device differ from other treatments for monitoring hospital patients?

The automated fluid output tracking device is unique because it continuously and automatically measures urine output, reducing the workload on healthcare staff and minimizing human error. Unlike traditional methods that require manual measurement, this device uses advanced sensors and technology to provide real-time data and alerts, making it more efficient and reliable for monitoring patients in critical care. ^{2 3 10 11 12}

Research Team

Chenyu Lin, MD

Principal Investigator

Duke University

Eligibility Criteria

This trial is for English-reading adults aged 18-80 who are scheduled for a stem cell transplant at the Duke ABMT clinic and have a Karnofsky Performance Scale score of 70 or above. It's not suitable for those with physical constraints that prevent standard toilet use, such as waste excretion through stoma or catheter.

Inclusion Criteria

Able to read/write English

Scheduled to undergo an allogeneic or autologous hematopoietic stem cell transplant for any cancer or non-cancer illness through the Duke ABMT clinic

Age 18-80 years

Exclusion Criteria

Inability to use toilet device due to physical constraints, e.g. waste excreted through stoma or catheter

Physician recommendation that patient does not use standard urine/stool collection hat during days 1-2 of HCT conditioning

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Inpatient Monitoring

Participants' hospital rooms are outfitted with the prototype toilet device to automatically track fluid output during their inpatient stay.

Duration of inpatient stay

Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after the inpatient stay

4 weeks

Treatment Details

Interventions

• Electronic Device for Toilet

Trial Overview The study is testing a prototype electronic device fitted onto toilets to automatically track fluid output from urine and stool in patients during their hospital stay. The device's accuracy will be compared to manual measurements by nurses.

Participant Groups

Group I: Device Experimental Treatment 1 Intervention

Patients use toilet device to measure fluid output and self-report event types

Group II: Control Active Control 1 Intervention

Collection in standard hats + nurses visually assessing fluid volumes

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Findings from Research

The PleurAlert system modernizes the traditional chest tube drainage container by incorporating electronic sensing and automated alert features, improving monitoring efficiency for nurses.

This enhanced device not only tracks fluid volume but also detects critical conditions and sends alerts directly to nurses' cell phones, potentially speeding up emergency responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PleurAlert: an augmented chest drainage system with electronic sensing, automated alerts and internet connectivity. Leeson, CE., Weaver, RA., Bissell, T., et al.[2012]

A new low-cost device has been developed to automatically sense and supervise urine output in critical care units, addressing a significant gap in current monitoring technologies.

The device uses a magnetic float and reed switches to measure urine collection and employs a siphon mechanism for automatic emptying, reducing the workload on healthcare staff and minimizing human error.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A low cost device for monitoring the urine output of critical care patients. Otero, A., Palacios, F., Akinfiev, T., et al.[2021]

The 'intelligent toilet' is designed to provide comprehensive health monitoring for patients with chronic conditions like diabetes and heart failure, making it easier for them to manage their health without needing extensive interaction with complex devices.

This innovative technology aims to improve the quality of medical care for chronically ill patients by integrating health checks into a familiar and simple-to-use system, potentially enhancing patient compliance and monitoring efficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unobtrusive and comprehensive health screening using an intelligent toilet system. Schlebusch, T., Fichtner, W., Mertig, M., et al.[2016]

The 'smart' toilet technology autonomously analyzes urine and stool, providing actionable health data through methods like colorimetric assays and deep learning, which can match the accuracy of trained medical personnel.

This innovative system allows for continuous health monitoring and could be particularly useful for screening and diagnosing specific patient populations, integrating seamlessly into clinical workflows.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A mountable toilet system for personalized health monitoring via the analysis of excreta. Park, SM., Won, DD., Lee, BJ., et al.[2022]

Automating urine output (UOP) monitoring in the intensive care unit using a weight-based device can significantly improve the timeliness of documentation, as many current manual recordings are often delayed by an average of 85 minutes.

The novel device demonstrated accuracy in UOP measurements, with values only differing by an average of 27 ml from nurse-documented values, indicating it can effectively reduce nursing workload without sacrificing precision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Fluid Output Monitoring in the Intensive Care Unit. Kushnir, A., Palte, E., Morris, N., et al.[2022]

The 'Safe Embrace' device was developed specifically to prevent falls among seniors using the toilet, addressing a significant safety concern that existing products did not meet.

After positive evaluations from health teams, patients, and caregivers during testing in a geriatric ward, the device was patented to promote its use in other institutions, highlighting its efficacy and commitment to user safety and privacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safe Embrace: technological innovation for elderly safety in the use of toilets. Niwa, LMS., Radovich, NMF., Ciosak, SI.[2021]

The Urine Monitoring Device (UMOD) is designed to enhance postoperative care by allowing real-time monitoring of urine flow, which helps healthcare providers track patient recovery more efficiently.

By automating urine monitoring and reducing the need for manual checks, the UMOD alleviates the workload on nursing staff, allowing them to focus on other critical patient care tasks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

UMOD: A Device for Monitoring Postoperative Urination. Katzis, K., Despotou, G., Jones, RW.[2018]

A new sensor system has been developed to detect incontinence events in elderly individuals, which can help identify patterns in their incontinence and support the creation of personalized toileting regimes.

Implementing these regimes can potentially reduce the reliance on incontinence pads, leading to improved quality of life for residents and lower care costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A system for logging incontinence events using a simple disposable sensor. Cusick, G., Birkett, A., Clarke-O'Neill, S., et al.[2019]

Smart toilets can play a significant role in precision health monitoring at home, providing valuable health data without requiring active participation from users.

However, the use of smart toilets raises important ethical considerations regarding privacy and data security that need to be addressed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Passive monitoring by smart toilets for precision health. Ge, TJ., Rahimzadeh, VN., Mintz, K., et al.[2023]

A new patent-pending device has been developed to automatically measure and monitor urine output in critical care patients, reducing the risk of human error and easing the workload for healthcare staff.

The device uses a high precision scale to accurately record urine output and transmits data via Bluetooth to a PC for real-time monitoring of therapeutic goals, and it is currently being tested at a research unit in Spain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A device for automatically measuring and supervising the critical care patient's urine output. Otero, A., Palacios, F., Akinfiev, T., et al.[2021]

A new non-invasive urinary flow monitoring device has been developed for critically ill patients, capable of real-time measurement of urine flow and color detection, which can help identify issues like hematuria.

The device demonstrated high accuracy in measuring urine flow rates (from less than 1 ml/h to 500 ml/h) with errors below 15% compared to a gold standard infusion pump, making it clinically adequate for monitoring renal function and diuresis patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a urinometer for automatic measurement of urine flow in catheterized patients. Lafuente, JL., González, S., Puertas, E., et al.[2023]

A new patent-pending device has been developed to continuously and accurately measure urine output (UO) in critical care patients, addressing a key area that is still manually monitored.

The device uses capacitive sensors to measure urine levels in two chambers, allowing for precise monitoring while reducing the need for frequent nursing interventions, thus minimizing human error and workload.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An automatic critical care urine meter. Otero, A., Fernandez, R., Apalkov, A., et al.[2021]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

PleurAlert: an augmented chest drainage system with electronic sensing, automated alerts and internet connectivity. [2012]

2. Switzerland pubmed.ncbi.nlm.nih.gov

A low cost device for monitoring the urine output of critical care patients. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

Unobtrusive and comprehensive health screening using an intelligent toilet system. [2016]

4. England pubmed.ncbi.nlm.nih.gov

A mountable toilet system for personalized health monitoring via the analysis of excreta. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Improving Fluid Output Monitoring in the Intensive Care Unit. [2022]

6. Brazil pubmed.ncbi.nlm.nih.gov

Safe Embrace: technological innovation for elderly safety in the use of toilets. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

UMOD: A Device for Monitoring Postoperative Urination. [2018]

8. England pubmed.ncbi.nlm.nih.gov

A system for logging incontinence events using a simple disposable sensor. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Passive monitoring by smart toilets for precision health. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

A device for automatically measuring and supervising the critical care patient's urine output. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Development of a urinometer for automatic measurement of urine flow in catheterized patients. [2023]

12. Switzerland pubmed.ncbi.nlm.nih.gov

An automatic critical care urine meter. [2021]