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

Recruiting in Palo Alto (17 mi)

Overseen byMichael McGillion, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Hamilton Health Sciences Corporation

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Maura Marcucci, M.D., MSc

Principal Investigator

McMaster University, Population Health Research Institute

Michael McGillion, PhD

Principal Investigator

McMaster University, Population Health Research Institute

Eligibility Criteria

Inclusion Criteria

Age ≥ 18 years

Healthy participant (no known significant health problems)

Provide informed consent to participate

Exclusion Criteria

Epilepsy

History of unexplained fainting/syncope

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

See 13 more

Treatment Details

Interventions

Vitaliti Continuous Vital Sign Monitor Model CVSM-1A (Continuous Vital Signs Monitor)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Vitaliti CVSM DeviceExperimental Treatment1 Intervention

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.