Multiparameter vital signs monitoring validation of the Corsano CardioWatch 287-2

Phase 4

Completed

• Conditions: angina pectoris; coronary artery disease; 10011082

• Registration Number: NL-OMON51353
• Lead Sponsor: Corsano Health B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

• >= 18 years old;
• undergoing invasive monitoring, like coronary angiography;
• able to provide consent.

Exclusion Criteria

Patients
• who cannot wear the Corsano CardioWatch 287 due to reasons such as allergic
reactions, wounds, amputations etc.;
• unable or not willing to sign informed consent;
• with significant mental or cognitive impairment;
• who do not have a suitable entry site for the invasive arterial line.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Root mean squared error between measurements (heart rate, RR-intervals,<br /><br>respiration rate, oxygen saturation, blood pressure) recorded by Corsano<br /><br>CardioWatch 287-2 and reference device.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Arithmetic mean and standard deviation of the error between blood pressure<br /><br>values measured by the Corsano CardioWatch 287-2 and the reference method<br /><br>according to ISO 81060-2:2018.</p><br>