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Automated Fluid Output Tracking Device for Monitoring Hospital Patients

N/A
Recruiting
Led By Anthony Sung, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after transition to stage 2 - about 3 days after patient begins hct conditioning
Awards & highlights

Study Summary

This trial will help researchers learn whether the prototype toilet device is accurate and easy to use. If the device is found to be accurate and user-friendly, it could be used in hospitals to help measure human fluid output.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves using an electronic device on a toilet rather than medication, traditional side effects are not expected. However, there may be privacy concerns or discomfort associated with the monitoring process.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after transition to stage 2 - about 3 days after patient begins hct conditioning
This trial's timeline: 3 weeks for screening, Varies for treatment, and after transition to stage 2 - about 3 days after patient begins hct conditioning for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean absolute error of urine volume (in mL) as measured by device compared to standard of care nurse assessment
Secondary outcome measures
Correlation between daily patient fluid balance (difference between fluid input and output in mL) as measured by device measurements or standard of care nurse assessment and the change in daily weight
Levels of chemotherapy drugs detectable on room surfaces as measured by surface testing
Mean absolute error of urine volume (in mL) as measured by device
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: DeviceExperimental Treatment1 Intervention
Patients use toilet device to measure fluid output and self-report event types
Group II: ControlActive Control1 Intervention
Collection in standard hats + nurses visually assessing fluid volumes

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,356 Previous Clinical Trials
3,409,047 Total Patients Enrolled
Anthony Sung, MDPrincipal InvestigatorDuke University
9 Previous Clinical Trials
648 Total Patients Enrolled

Media Library

Electronic Device for Toilet Clinical Trial Eligibility Overview. Trial Name: NCT05520346 — N/A
Fluid Output Research Study Groups: Device, Control
Fluid Output Clinical Trial 2023: Electronic Device for Toilet Highlights & Side Effects. Trial Name: NCT05520346 — N/A
Electronic Device for Toilet 2023 Treatment Timeline for Medical Study. Trial Name: NCT05520346 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to join this clinical trial?

"This clinical trial is looking to enroll 54 individuals with a history of fluid output, aged 18-80 years old. Other criteria for recruitment include: eligibility for autologous or allogeneic hematopoietic stem cell transplants through Duke ABMT clinic, Karnofsky Performance Scale KPS ≥ 70, and literacy in the English language."

Answered by AI

Are there any vacancies in this clinical trial for prospective participants?

"Clinicaltrials.gov reports that this trial, which commenced on the 1st of January 2023 and was last updated on November 28th 2022, is not currently accepting applicants. However, there are other medical studies in need of volunteers at present."

Answered by AI

Are those over the age of 75 precluded from participating in this research?

"As specified in the prerequisites for involvement, participants must be between 18 and 80 years old."

Answered by AI
~34 spots leftby Feb 2025