Blood Pressure Clinical Trial
— VERDICT-2Official title:
Verification Protocol for the Cloud DX Vitaliti Continuous Vital Signs Monitor (Model CVSM-1A) for Clinical Use and Self Measurement in Ambulatory Settings
Verified date | May 2024 |
Source | Hamilton Health Sciences Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 35 |
Est. completion date | September 19, 2023 |
Est. primary completion date | September 19, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | McMaster University | Hamilton | Ontario |
Lead Sponsor | Collaborator |
---|---|
Hamilton Health Sciences Corporation | Cloud DX Inc., McMaster University, Population Health Research Institute |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Respiration Rate | 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. | 44 Minutes | |
Primary | Pulse Rate | 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). | 27 Minutes | |
Primary | Oxyhemoglobin Saturation | 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. | 27 Minutes | |
Primary | Temperature | 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. | 12 Minutes | |
Primary | Heart Rate | 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). | 36 Minutes | |
Primary | Blood Pressure | 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. | 30 Minutes |
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