Validation of a Vital Signs Monitoring Wristband (MULTI-VITAL)

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Continuous measurement of photoplethysmography at the wrist

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Netherlands
  • Zuid Holland
    • Delft, Zuid Holland, Netherlands, 2625 AD
      • Reinier de Graaf Gasthuis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to coronary angiography

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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 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

Collaborators and Investigators

• Sponsor: Corsano Health B.V.

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2022
• Primary Completion (Actual): February 7, 2023
• Study Completion (Actual): February 7, 2023

Study Registration Dates

• First Submitted: September 20, 2022
• First Submitted That Met QC Criteria: October 1, 2022
• First Posted (Actual): October 4, 2022

Study Record Updates

• Last Update Posted (Actual): May 4, 2025
• Last Update Submitted That Met QC Criteria: April 16, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Blood pressure; Heart rate; Oxygen saturation; Respiratory rate; Vital signs
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: MULTI-VITAL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No