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

Blood Pressure Clinical Trial

— VERDICT-2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05886153
• Other study ID #: v2.0_2023-01-05
• Status: Completed
• Phase: N/A
• Start date: August 22, 2023
• Est. completion date: September 19, 2023

Study information

• Verified date: May 2024
• Source: Hamilton Health Sciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: September 19, 2023
• Est. primary completion date: September 19, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

1. Age = 18 years

2. Healthy participant (no known significant health problems)

3. Provide informed consent to participate

Exclusion Criteria:

1. Active smoker

2. Recent exposure to carbon monoxide

3. Have unexplained shortness of breath at rest

4. Pregnant

5. Hearing aid/Cochlear Implant

6. Current arrhythmia

7. ICD/Pacemaker

8. Current respiratory disease/infection

9. Significant body tremors/shaking

10. Epilepsy

11. History of unexplained fainting/syncope

12. Have any disorder that prohibits placement of the device (i.e., skin rash/abrasion, open or infected sore)

13. Cerebrospinal Fluid Shunt

14. Unable to ambulate, stand, or lay in supine position

15. Allergy to adhesive

16. Unable to understand or speak English

Related Conditions & MeSH terms

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

Intervention

Device:
• Vitaliti Continuous Vital Sign Monitor Model CVSM-1A
Measurements recorded by the Vitaliti CVSM device will be compared to the recordings from various standardized comparator devices.

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation	Cloud DX Inc., McMaster University, Population Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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