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Completed

NCT Number: NCT05886153

Verification Protocol for the Cloud DX Vitaliti Continuous Vital Signs Monitor (VERDICT-2)

The VERDICT-2 verification study will examine the accuracy of the Cloud DX Vitaliti Continuous Vital Signs Monitor (Model: CVSM-1A) in an ambulatory context with healthy participants. The objective is to determine the accuracy of continuous non-invasive vital signs metrics including respiration, pulse rate, oxyhemoglobin saturation (SpO2), core temperature, heart rate, and cNIBP against standard comparator devices guided by consensus standards.

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Key information

Conditions

Blood Pressure Heart Rate Oxygen Saturation Pathologic Processes Pathological Conditions, Signs and Symptoms Pulse Rate Respiration Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases Temperature

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McMaster University

Hamilton, Ontario, L8S 4L8, Canada

About this study

Effective postoperative care is faced with several challenges- patients experience major complications following surgery, which often require re-hospitalization or utilization of healthcare services (i.e., emergency room visits) once discharged into the community. New remote automated monitoring (RAM) technologies that enable data integration, synthesis, and real-time alerts to clinicians have the potential to transform postoperative care, similar to how intraoperative care has evolved.

The Cloud DX Vitaliti Continuous Vital Signs Monitor (Model: CVSM-1A) is a continuous vital sign monitor intended to measure vital metrics including systolic and diastolic blood pressures (via ECG/ photoplethysmography [PPG]), pulse (via PPG), respiration rate (via impedance respiration waveform), core body temperature (via infrared sensor), and blood oxygen saturation levels (via PPG) of an adult individual using non-invasive techniques.

The VERDICT-2 verification study will examine the accuracy of the Vitaliti CVSM in an ambulatory context with healthy participants.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age ≥ 18 years
  • Healthy participant (no known significant health problems)
  • Provide informed consent to participate

Exclusion criteria

  • Active smoker
  • Recent exposure to carbon monoxide
  • Have unexplained shortness of breath at rest
  • Pregnant
  • Hearing aid/Cochlear Implant
  • Current arrhythmia
  • ICD/Pacemaker
  • Current respiratory disease/infection
  • Significant body tremors/shaking
  • Epilepsy
  • History of unexplained fainting/syncope
  • Have any disorder that prohibits placement of the device (i.e., skin rash/abrasion, open or infected sore)
  • Cerebrospinal Fluid Shunt
  • Unable to ambulate, stand, or lay in supine position
  • Allergy to adhesive
  • Unable to understand or speak English

Treatment and study plan

Vitaliti Continuous Vital Sign Monitor Model CVSM-1A

Device

Measurements recorded by the Vitaliti CVSM device will be compared to the recordings from various standardized comparator devices.

Primary outcomes

  1. Respiration Rate

    Time frame: 44 Minutes

    Determining the accuracy of the impedance respiration waveform on the Vitaliti device to measure respiration rate, compared to an appropriate standardized comparator device. The Vitaliti CVSM will be evaluated against performance criteria determined to be clinically relevant, in alignment with predicate devices, and as defined by the manufacturer, since there are no internationally recognized consensus standards.

  2. Pulse Rate

    Time frame: 27 Minutes

    Determining the accuracy of the ECG/photoplethysmography (PPG) on the Vitaliti device to measure pulse rate, compared to an appropriate standardized comparator device. Detailed analysis will be conducted to verify accuracy of the Vitaliti device against performance criteria as defined in IEC 60601-2-27:2011/ (R2016).

  3. Oxyhemoglobin Saturation

    Time frame: 27 Minutes

    Determining the accuracy of the electrocardiogram (ECG)/photoplethysmography (PPG) on the Vitaliti device to measure blood oxygen saturation, compared to an appropriate standardized comparator device. A detailed analysis will be performed to compare the Vitaliti device against performance criteria as defined in ISO 80601-2-61:2017, MOD.

  4. Temperature

    Time frame: 12 Minutes

    Determining the accuracy of the infrared sensor on the Vitaliti device to measure core body temperature, compared to an appropriate standardized comparator device. A detailed analysis will be conducted to verify accuracy of the Vitaliti device against performance criteria as defined in ISO 80601-2-56:2017/AMD-1:2018.

  5. Heart Rate

    Time frame: 36 Minutes

    Determining the accuracy of the electrocardiogram (ECG) on the Vitaliti device to measure heart rate, compared to an appropriate standardized comparator device. A detailed analysis will be conducted to verify accuracy of the Vitaliti device against performance criteria as defined in IEC 60601-2-27:2011/ (R2016).

  6. Blood Pressure

    Time frame: 30 Minutes

    Determining the accuracy of the electrocardiogram (ECG)/photoplethysmography (PPG) on the Vitaliti device to measure blood pressure, compared to an appropriate standardized comparator device. A detailed analysis will be conducted to verify accuracy against performance criteria as defined in ISO 81060-2: 2018/AMD-1:2020.

Sponsors and collaborators

Lead sponsor

Hamilton Health Sciences Corporation

Other

Collaborators

  • Cloud DX Inc.
  • McMaster University
  • Population Health Research Institute

Registry information

Official study title

Verification Protocol for the Cloud DX Vitaliti Continuous Vital Signs Monitor (Model CVSM-1A) for Clinical Use and Self Measurement in Ambulatory Settings

Acronym: VERDICT-2

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 2, 2023
Registry last updated
Jun 3, 2024

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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