Validation of a Vital Signs Monitoring Wristband

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT05566886
• Lead Sponsor: Corsano Health B.V.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-20
• Study First Submitted QC: 2022-10-01
• Study First Posted: 2022-10-04
• Study Start: 2022-10-19
• Primary Completion: 2023-02-07
• Study Completion: 2023-02-07
• Results First Submitted: 2024-11-29
• Status Verified: 2025-04
• Results First Submitted QC: 2025-04-16
• Last Update Submitted: 2025-04-16
• Results First Posted: 2025-05-04
• Last Update Posted: 2025-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• 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
• who do not comply to criteria established by ISO 81060-2:2018.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
RMSE of Heart Rate	30 minutes	Root-mean-squared error between PPG measured and gold standard measured heart rate
RMSE of Respiratory Rate	30 minutes	Root-mean-squared error between PPG measured and gold standard measured respiratory rate
RMSE of Oxygen Saturation	30 minutes	Root-mean-squared error between PPG measured and gold standard measured oxygen saturation
RMSE of Blood Pressure	30 minutes	Root-mean-squared error between PPG measured and gold standard measured blood pressure (systolic blood pressure and diastolic blood pressure)

Trial Locations

Locations (1)

Reinier de Graaf Gasthuis; 🇳🇱 Delft, Zuid Holland, Netherlands