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

• Sponsor: Centre Hospitalier Universitaire de Nīmes (Other)
• Overall Status: Completed
• CT.gov ID: NCT03408288
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Actual Duration (Days): 16
• Patients Per Site Per Month: 38

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hematuria	Other: Hemapoche; Other: Hemastick; Other: Color description

Study Design

• Study Type: Observational
• Actual Enrollment: 20 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Value of an Integral Color Scale on Urine Collection Bags Versus Use of a Strip in Description of Hematuria.
• Actual Study Start Date: Jan 16, 2018
• Actual Primary Completion Date: Feb 1, 2018
• Actual Study Completion Date: Feb 1, 2018

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

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

   Kappa coefficient

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

   Kappa coefficient

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

   Kappa coefficient

Secondary Outcome Measures

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

   Kappa coefficient

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

   Kappa coefficient

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

   Kappa coefficient

4. Time needed to characterize hematuria when using Hemapoche [Baseline]

   Seconds (less than one minute)

5. Time needed to characterize hematuria when using Hemostick [Baseline]

   Seconds (less than one minute)

6. Time needed to characterize hematuria when using color description [Baseline]

   Seconds (less than one minute)

7. Satisfaction of medical staff in using Hemapoche medical device [Baseline]

   Visual analog scale (0-10)

8. Usability scale of Hemapoche device according to medical staff [Baseline]

   System usability scale (0-10)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Nimes	Nîmes		France	30029

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Nīmes

Investigators

• Principal Investigator: Armand Chevrot, MD, CHU Nimes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de Nīmes
• ClinicalTrials.gov Identifier: NCT03408288
• Other Study ID Numbers: NIMAO/2017-02/AC-01
• First Posted: Jan 24, 2018
• Last Update Posted: Jul 3, 2018
• Last Verified: Jan 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hematuria

Study Results

No Results Posted as of Jul 3, 2018