CompletedNCT03408288HEMAPOCHEUpdated Jul 3, 2018

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

An observational study in Hematuria, sponsored by Centre Hospitalier Universitaire de Nīmes. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-03.

Sponsored by Centre Hospitalier Universitaire de Nīmes · Observational

Study type: Observational
Model: Other
Time perspective: Prospective
Enrollment: 20
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Hematuria

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Hematuria 58

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes
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

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

Exclusion Criteria:

The participant has color-blindness
Nurse or urologist from the urology department of Nimes

Study design

Observational model: Other
Time perspective: Prospective
Enrollment: 20 participants (actual)
Patient registry: No

Groups and cohorts

Nurses
Other: Hemapoche · Other: Hemastick · Other: Color description
Urologists
Other: Hemapoche · Other: Hemastick · Other: Color description

Interventions

OtherHemapoche
Use of Hemapoche scale to assess hematuria in reference samples
OtherHemastick
Use of Hemastick scale to assess hematuria in reference samples
OtherColor description
Describe color of reference sample

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

1 site

CHU Nimes
Nîmes, 30029, France

Registry details

Key details

Study ID: NCT03408288
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Responsible party: Sponsor
First posted: Jan 24, 2018
Start date: Jan 16, 2018
Primary completion: Feb 1, 2018
Completion: Feb 1, 2018
Last update: Jul 3, 2018

Study contacts

Armand Chevrot, MD

principal investigator · CHU Nimes

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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