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

July 2, 2018 updated by: Centre Hospitalier Universitaire de Nīmes
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nîmes, France, 30029
        • CHU Nîmes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Nurses volunteering to take part in the study outside of the urology department of CHU Nimes and a panel of urologist experts

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Nurses
Other: Hemapoche
Use of Hemapoche scale to assess hematuria in reference samples
Other: Hemastick
Use of Hemastick scale to assess hematuria in reference samples
Other: Color description
Describe color of reference sample
Urologists
Other: Hemapoche
Use of Hemapoche scale to assess hematuria in reference samples
Other: Hemastick
Use of Hemastick scale to assess hematuria in reference samples
Other: Color description
Describe color of reference sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intra-user concordance in assessment of hematuria score measured by Hemapoche
Time Frame: Baseline
Kappa coefficient
Baseline
Intra-user concordance in assessment of hematuria score measured by Hemostick
Time Frame: Baseline
Kappa coefficient
Baseline
Intra-user concordance in assessment of hematuria described by color of urine
Time Frame: Baseline
Kappa coefficient
Baseline

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Investigators

  • Principal Investigator: Armand Chevrot, MD, CHU Nîmes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 16, 2018

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

January 17, 2018

First Submitted That Met QC Criteria

January 17, 2018

First Posted (Actual)

January 24, 2018

Study Record Updates

Last Update Posted (Actual)

July 3, 2018

Last Update Submitted That Met QC Criteria

July 2, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIMAO/2017-02/AC-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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