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

NCT05886153 | Completed

• 1 other identifier: v2.0_2023-01-05
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Blood Pressure; Respiration; Pulse Rate; Oxygen Saturation; Temperature; Heart Rate

Outcome Measures

Primary Outcomes (6)

• Respiration Rate

  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.

  44 Minutes

• Pulse Rate

  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).

  27 Minutes

• Oxyhemoglobin Saturation

  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.

  27 Minutes

• Temperature

  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.

  12 Minutes

• Heart Rate

  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).

  36 Minutes

• Blood Pressure

  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.

  30 Minutes

Study Arms (1)

Vitaliti CVSM Device

OTHER

Examine the accuracy of the Cloud DX Vitaliti Continuous Vital Signs Monitor (Model: CVSM-1A) in an ambulatory context with healthy participants 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.

Device: Vitaliti Continuous Vital Sign Monitor Model CVSM-1A

Interventions

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.

Vitaliti CVSM Device

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• McMaster University: collaborator
• Population Health Research Institute: collaborator
• Cloud DX Inc.: collaborator

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4L8, Canada

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Maura Marcucci, M.D., MSc

  McMaster University, Population Health Research Institute

  PRINCIPAL INVESTIGATOR

• Michael McGillion, PhD

  McMaster University, Population Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single group verification testing of the Vitaliti Continuous Vital Sign Monitor Model CVSM-1A device

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: June 2, 2023
• Study Start: August 22, 2023
• Primary Completion: September 19, 2023
• Study Completion: September 19, 2023
• Last Updated: June 3, 2024

Record last verified: 2024-05

Locations

CA (1)