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OpenTrials
Completed

NCT Number: NCT03408288

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

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.

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Key information

Conditions

Hematuria Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hemorrhage Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Nimes

Nîmes, 30029, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hemapoche

Other

Use of Hemapoche scale to assess hematuria in reference samples

Hemastick

Other

Use of Hemastick scale to assess hematuria in reference samples

Color description

Other

Describe color of reference sample

Primary outcomes

  1. Intra-user concordance in assessment of hematuria score measured by Hemapoche

    Time frame: Baseline

    Kappa coefficient

  2. Intra-user concordance in assessment of hematuria score measured by Hemostick

    Time frame: Baseline

    Kappa coefficient

  3. Intra-user concordance in assessment of hematuria described by color of urine

    Time frame: Baseline

    Kappa coefficient

Secondary outcomes

  1. Concordance between nurses versus doctors in assessment of hematuria score measured by Hemapoche

    Time frame: Baseline

    Kappa coefficient

  2. Concordance between nurses versus doctors in assessment of hematuria score measured by Hemastick

    Time frame: Baseline

    Kappa coefficient

  3. Concordance between nurses versus doctors in assessment of hematuria described by color

    Time frame: Baseline

    Kappa coefficient

  4. Time needed to characterize hematuria when using Hemapoche

    Time frame: Baseline

    Seconds (less than one minute)

  5. Time needed to characterize hematuria when using Hemostick

    Time frame: Baseline

    Seconds (less than one minute)

  6. Time needed to characterize hematuria when using color description

    Time frame: Baseline

    Seconds (less than one minute)

  7. Satisfaction of medical staff in using Hemapoche medical device

    Time frame: Baseline

    Visual analog scale (0-10)

  8. Usability scale of Hemapoche device according to medical staff

    Time frame: Baseline

    System usability scale (0-10)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: HEMAPOCHE

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 24, 2018
Registry last updated
Jul 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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