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

Hamilton Health Sciences (HHS)

Status: Completed

Conditions: Oxygen Saturation; Respiration; Temperature; Heart Rate; Pulse Rate; Blood Pressure

Treatments: Device: Vitaliti Continuous Vital Sign Monitor Model CVSM-1A

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05886153

v2.0_2023-01-05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Vitaliti CVSM Device

Other group

Description:

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.

Treatment:

Device: Vitaliti Continuous Vital Sign Monitor Model CVSM-1A