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

• Sponsor: Hamilton Health Sciences Corporation (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05886153
• Collaborator: McMaster University (Other), Population Health Research Institute (Other), Cloud DX Inc. (Industry)
• Enrollment: 35
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 2
• Patients Per Site Per Month: 17.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Blood Pressure; Respiration; Pulse Rate; Oxygen Saturation; Temperature; Heart Rate	Device: Vitaliti Continuous Vital Sign Monitor Model CVSM-1A	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 35 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Single group verification testing of the Vitaliti Continuous Vital Sign Monitor Model CVSM-1A deviceSingle group verification testing of the Vitaliti Continuous Vital Sign Monitor Model CVSM-1A device
• Masking: None (Open Label)
• Primary Purpose: Other
• 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
• Anticipated Study Start Date: Jun 1, 2023
• Anticipated Primary Completion Date: Aug 1, 2023
• Anticipated Study Completion Date: Aug 1, 2023

Arms and Interventions

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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).

3. 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.

4. 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.

5. 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).

6. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	McMaster University	Hamilton	Ontario	Canada	L8S 4L8

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Maura Marcucci, M.D., MSc, McMaster University, Population Health Research Institute
• Principal Investigator: Michael McGillion, PhD, McMaster University, Population Health Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hamilton Health Sciences Corporation
• ClinicalTrials.gov Identifier: NCT05886153
• Other Study ID Numbers: v2.0_2023-01-05
• First Posted: Jun 2, 2023
• Last Update Posted: Jun 2, 2023
• Last Verified: May 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jun 2, 2023