NCT05886153

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Hamilton Health Sciences Corporation · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-08-22
• Primary completion: 2023-09-19
• Completion: 2023-09-19
• First posted: 2023-06-02
• Last updated: 2024-06-03

Locations

1 site across 1 country: Canada