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NCT03408288 Clinical Trial

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

Hematuria Clinical Trial

— HEMAPOCHE  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03408288
Other study ID # NIMAO/2017-02/AC-01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 16, 2018
Est. completion date February 1, 2018

Study information
Verified date January 2018
Source Centre Hospitalier Universitaire de Nimes
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date February 1, 2018
Est. primary completion date February 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Hemapoche
Use of Hemapoche scale to assess hematuria in reference samples
• Hemastick
Use of Hemastick scale to assess hematuria in reference samples
• Color description
Describe color of reference sample

Locations
Country Name City State
France CHU Nimes Nîmes

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Intra-user concordance in assessment of hematuria score measured by Hemapoche Kappa coefficient Baseline
Primary Intra-user concordance in assessment of hematuria score measured by Hemostick Kappa coefficient Baseline
Primary Intra-user concordance in assessment of hematuria described by color of urine Kappa coefficient Baseline
Secondary Concordance between nurses versus doctors in assessment of hematuria score measured by Hemapoche Kappa coefficient Baseline
Secondary Concordance between nurses versus doctors in assessment of hematuria score measured by Hemastick Kappa coefficient Baseline
Secondary Concordance between nurses versus doctors in assessment of hematuria described by color Kappa coefficient Baseline
Secondary Time needed to characterize hematuria when using Hemapoche Seconds (less than one minute) Baseline
Secondary Time needed to characterize hematuria when using Hemostick Seconds (less than one minute) Baseline
Secondary Time needed to characterize hematuria when using color description Seconds (less than one minute) Baseline
Secondary Satisfaction of medical staff in using Hemapoche medical device Visual analog scale (0-10) Baseline
Secondary Usability scale of Hemapoche device according to medical staff System usability scale (0-10) Baseline
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