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

Not Applicable

Completed

• Conditions: Respiration; Pulse Rate; Oxygen Saturation; Heart Rate; Blood Pressure; Temperature
• Interventions: Device: Vitaliti Continuous Vital Sign Monitor Model CVSM-1A

• Registration Number: NCT05886153
• Lead Sponsor: Hamilton Health Sciences Corporation

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-05-23
• Study First Submitted QC: 2023-05-23
• Study First Posted: 2023-06-02
• Study Start: 2023-08-22
• Primary Completion: 2023-09-19
• Study Completion: 2023-09-19
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-30
• Last Update Posted: 2024-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vitaliti CVSM Device	Vitaliti Continuous Vital Sign Monitor Model CVSM-1A	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.

Primary Outcome Measures

Name	Time	Method
Pulse Rate	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).
Oxyhemoglobin Saturation	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.
Heart Rate	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).
Blood Pressure	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.
Respiration Rate	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.
Temperature	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.

Trial Locations

Locations (1)

McMaster University; 🇨🇦 Hamilton, Ontario, Canada