Minicare I-20 cTnI usability testing in the ambulance setting at Witte Kruis.

Minicare I-20 cTnI usability testing in the ambulance setting at Witte Kruis. - Minicare I-20 cTnI usability testing in the ambulance setting

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON42842

Enrollment

100

Registered

2017-01-16

Start date

2016-12-27

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

accute coronary syndrome heart failure

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 18 years old or older suspicion of acute heart failure

Exclusion criteria

Exclusion criteria: younger than 18 years old no suspicion for accute heart failure non-consenting

Design outcomes

Primary

Measure	Time frame
The usability and user acceptance will be measured by means of questionnaires and interviews [Appendix B] designed to extract usability information from the paramedics who have been using the Minicare I-20 system in the field. The following topics will be addressed: * Ease of use of the analyzer * The fit in EMS workflow * Cartridge storage * Analyzer storage * Ease of device portability * Usability of the case designs Device performance Analysis of analyzer log files and Patient result forms will allow to assess: * Device performance (Non-Reportable rate, LOG file errors) * Device performance in carry case Analyzer/Cartridge storage cases. The usability and user acceptance will be measured by means of questionnaires and interviews [Appendix B] designed to extract usability information from the paramedics who have been using the Minicare I-20 system in the field. The following topics will be addressed * Usability of the case designs * Fit in the ambulance * Transport to patient * Workflow improvement compared to no-case? * Cartridge cooling Acceptance criteria * At least 5 patients tested by at least 10 paramedics. * Questionnaires from at least 10 paramedics	—

Measure

Time frame

The usability and user acceptance will be measured by means of questionnaires and interviews [Appendix B] designed to extract usability information from the paramedics who have been using the Minicare I-20 system in the field. The following topics will be addressed: * Ease of use of the analyzer * The fit in EMS workflow * Cartridge storage * Analyzer storage * Ease of device portability * Usability of the case designs Device performance Analysis of analyzer log files and Patient result forms will allow to assess: * Device performance (Non-Reportable rate, LOG file errors) * Device performance in carry case Analyzer/Cartridge storage cases. The usability and user acceptance will be measured by means of questionnaires and interviews [Appendix B] designed to extract usability information from the paramedics who have been using the Minicare I-20 system in the field. The following topics will be addressed * Usability of the case designs * Fit in the ambulance * Transport to patient * Workflow improvement compared to no-case? * Cartridge cooling Acceptance criteria * At least 5 patients tested by at least 10 paramedics. * Questionnaires from at least 10 paramedics

—

Secondary

Measure	Time frame
N.A.	—

Countries

Netherlands

Outcome results