Validation of a Vital Signs Monitoring Wristband

Coronary Artery Disease Clinical Trial

— MULTI-VITAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05566886
• Other study ID #: MULTI-VITAL
• Status: Completed
• Start date: October 19, 2022
• Est. completion date: February 7, 2023

Study information

• Verified date: April 2023
• Source: Corsano Health B.V.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 7, 2023
• Est. primary completion date: February 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

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

Locations

Country	Name	City	State
Netherlands	Reinier de Graaf Gasthuis	Delft	Zuid Holland

Sponsors (1)

Lead Sponsor	Collaborator
Corsano Health B.V.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RMSE of heart rate	Root-mean-squared error between PPG measured and gold standard measured heart rate	30 minutes
Primary	RMSE of interbeat intervals	Root-mean-squared error between PPG measured and gold standard measured interbeat intervals	30 minutes
Primary	RMSE of respiratory rate	Root-mean-squared error between PPG measured and gold standard measured respiratory rate	30 minutes
Primary	RMSE of oxygen saturation	Root-mean-squared error between PPG measured and gold standard measured oxygen saturation	30 minutes
Primary	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