Validation of a Vital Signs Monitoring Wristband

NCT05566886 | Completed Results FDA Device

• 1 other identifier: MULTI-VITAL
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

Vital signs; Blood pressure; Oxygen saturation; Heart rate; Respiratory rate

Outcome Measures

Primary Outcomes (4)

• 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

Interventions

Continuous measurement of photoplethysmography at the wrist DEVICE

Patients receive a wristband that uses multi-color LEDs to measure pulsations at the wrist.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to coronary angiography

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Corsano Health B.V.: lead

Study Sites (1)

Reinier de Graaf Gasthuis

Delft, South Holland, 2625 AD, Netherlands

Location

Related Publications (2)

• Monnink SHJ, van Vliet M, Kuiper MJ, Constandse JC, Hoftijzer D, Muller M, Ronner E. Clinical evaluation of a smart wristband for monitoring oxygen saturation, pulse rate, and respiratory rate. J Clin Monit Comput. 2025 Apr;39(2):451-457. doi: 10.1007/s10877-024-01229-z. Epub 2024 Oct 10.

  PMID: 39388061 DERIVED

• van Vliet M, Monnink SHJ, Kuiper MJ, Constandse JC, Hoftijzer D, Ronner E. Evaluation of a novel cuffless photoplethysmography-based wristband for measuring blood pressure according to the regulatory standards. Eur Heart J Digit Health. 2024 Feb 8;5(3):335-343. doi: 10.1093/ehjdh/ztae006. eCollection 2024 May.

  PMID: 38774367 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Clinical Research Manager
• Organization: Corsano Health B.V.

info@corsano.com

+31 61 640 7778

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2022
• First Posted: October 4, 2022
• Study Start: October 19, 2022
• Primary Completion: February 7, 2023
• Study Completion: February 7, 2023
• Last Updated: May 4, 2025
• Results First Posted: May 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)