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

Completed

• Conditions: Hematuria
• Interventions: Other: Hemapoche; Other: Hemastick; Other: Color description

• Registration Number: NCT03408288
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-01
• Study Start: 2018-01-16
• Study First Submitted: 2018-01-17
• Study First Submitted QC: 2018-01-17
• Study First Posted: 2018-01-24
• Primary Completion: 2018-02-01
• Study Completion: 2018-02-01
• Last Update Submitted: 2018-07-02
• Last Update Posted: 2018-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Urologists	Hemapoche	-
Nurses	Hemapoche	-
Nurses	Color description	-
Urologists	Hemastick	-
Nurses	Hemastick	-
Urologists	Color description	-

Primary Outcome Measures

Name	Time	Method
Intra-user concordance in assessment of hematuria score measured by Hemostick	Baseline	Kappa coefficient
Intra-user concordance in assessment of hematuria score measured by Hemapoche	Baseline	Kappa coefficient
Intra-user concordance in assessment of hematuria described by color of urine	Baseline	Kappa coefficient

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU Nimes; 🇫🇷 Nîmes, France