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OpenTrials
Completed

NCT Number: NCT05566886

Validation of a Vital Signs Monitoring Wristband

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Reinier de Graaf Gasthuis

Delft, South Holland, 2625 AD, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Continuous measurement of photoplethysmography at the wrist

Device

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

Primary outcomes

  1. RMSE of Heart Rate

    Time frame: 30 minutes

    Root-mean-squared error between PPG measured and gold standard measured heart rate

  2. RMSE of Respiratory Rate

    Time frame: 30 minutes

    Root-mean-squared error between PPG measured and gold standard measured respiratory rate

  3. RMSE of Oxygen Saturation

    Time frame: 30 minutes

    Root-mean-squared error between PPG measured and gold standard measured oxygen saturation

  4. RMSE of Blood Pressure

    Time frame: 30 minutes

    Root-mean-squared error between PPG measured and gold standard measured blood pressure (systolic blood pressure and diastolic blood pressure)

Sponsors and collaborators

Lead sponsor

Corsano Health B.V.

Industry

Registry information

Official study title

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

Acronym: MULTI-VITAL

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 4, 2022
Registry last updated
May 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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