Validation of a Vital Signs Monitoring Wristband

Study Overview
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Brief Summary
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Today, continuous monitoring of vital signs remains a challenge since it generally requires the patient to be connected to multiple wired sensors, which restricts patient mobility in the intra-mural setting and complicates home monitoring in the extra-mural setting. Wearable devices on the wrist, although emerging, are often not clinically validated or limited to the monitoring of one or two vital signs. This study aims to validate the Corsano CardioWatch 287-2 for the continuous monitoring of heart rate at ≤ 4 bpm root mean squared error (RMSE); interbeat intervals at ≤ 50 ms RMSE; breathing rate at ≤ 2 brpm RMSE; and peripheral oxygen saturation at ≤ 3 percentage point RMSE. Also, this study aims to validate the Corsano CardioWatch 287-2 for the measurement of non-invasive blood pressure according to ISO 81060-2:2018.

Official Title
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Multi Parameter Vital Signs Monitoring by the Corsano CardioWatch 287-2 Validation Study

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Continuous measurement of photoplethysmography at the wrist


Participation Criteria
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Eligibility Criteria
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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 who do not comply to criteria established by ISO 81060-2:2018.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Continuous measurement of photoplethysmography at the wrist|Patients receive a wristband that uses multi-color LEDs to measure pulsations at the wrist.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RMSE of heart rate | Root-mean-squared error between PPG measured and gold standard measured heart rate | 30 minutes | 
| RMSE of interbeat intervals | Root-mean-squared error between PPG measured and gold standard measured interbeat intervals | 30 minutes | 
| RMSE of respiratory rate | Root-mean-squared error between PPG measured and gold standard measured respiratory rate | 30 minutes | 
| RMSE of oxygen saturation | Root-mean-squared error between PPG measured and gold standard measured oxygen saturation | 30 minutes | 
| RMSE of blood pressure | Root-mean-squared error between PPG measured and gold standard measured blood pressure (systolic blood pressure and diastolic blood pressure) | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vital signs, Blood pressure, Oxygen saturation, Heart rate, Respiratory rate