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Value of an Integral Color Scale on Urine Collection Bags Versus Use of a Strip in Description of Hematuria.

Value of an Integral Color Scale on Urine Collection Bags Versus Use of a Strip in Description of Hematuria.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03408288
Acronym
HEMAPOCHE
Enrollment
20
Registered
2018-01-24
Start date
2018-01-16
Completion date
2018-02-01
Last updated
2018-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematuria

Brief summary

The investigators hypothesize that incorporation of a colorimetric scale on urine collection bags to estimate degree of hematuria would allow better characterization of urine by healthcare staff thus leading to improved patient care.

Interventions

OTHERHemapoche

Use of Hemapoche scale to assess hematuria in reference samples

OTHERHemastick

Use of Hemastick scale to assess hematuria in reference samples

OTHERColor description

Describe color of reference sample

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* The participant is at least 18 year old * Nurses recruited voluntarily in the CHU Nimes outside of the Urology department of any duration of experience * Urologist working in the Languedoc-Roussillon region

Exclusion criteria

* The participant has color-blindness * Nurse or urologist from the urology department of Nimes

Design outcomes

Primary

MeasureTime frameDescription
Intra-user concordance in assessment of hematuria score measured by HemapocheBaselineKappa coefficient
Intra-user concordance in assessment of hematuria score measured by HemostickBaselineKappa coefficient
Intra-user concordance in assessment of hematuria described by color of urineBaselineKappa coefficient

Secondary

MeasureTime frameDescription
Time needed to characterize hematuria when using HemapocheBaselineSeconds (less than one minute)
Time needed to characterize hematuria when using HemostickBaselineSeconds (less than one minute)
Concordance between nurses versus doctors in assessment of hematuria score measured by HemapocheBaselineKappa coefficient
Satisfaction of medical staff in using Hemapoche medical deviceBaselineVisual analog scale (0-10)
Usability scale of Hemapoche device according to medical staffBaselineSystem usability scale (0-10)
Time needed to characterize hematuria when using color descriptionBaselineSeconds (less than one minute)
Concordance between nurses versus doctors in assessment of hematuria score measured by HemastickBaselineKappa coefficient
Concordance between nurses versus doctors in assessment of hematuria described by colorBaselineKappa coefficient

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026