Blood Pressure
Conditions
Keywords
Non-invasive blood pressure monitoring, Wearable device, Medical device verification study
Brief summary
The purpose of this study is the verification of Cloud-DX Vitaliti™ Continuous Automated Non-Invasive Blood Pressure Monitor for Clinical Use and Self Measurement according to standards laid out by IEEE Std 1708 and AAMI-ISO 81060-2.
Detailed description
Several automated vital sign measurement systems have been developed recently; however, non-invasive continuous blood pressure monitoring continues to be a major limitation. To circumvent the limitations of current systems of interval hemodynamic measurement and increasing demands on health care providers, a non-invasive automated continuous vital sign monitor that can integrate into hospital early warning systems and warn health care providers of deteriorating vital sign parameters would be of significant value and a major advance for current hospital monitoring systems. Cloud-DX Vitaliti™ is a new low profile automated vital sign monitor, which includes a continuous non-invasive blood pressure measurement system. Additional parameters are also measured. Paired with companion software from cloud based computing, Vitaliti™ features a user friendly interface, onboard radios for communication with smartphones/tablets/personal computers, and several sensors. Cloud-DX Vitaliti™ has undergone preliminary testing and is now ready for verification to achieve compliance with AAMI/ISO and IEEE standards of medical grade device. At the Hamilton General Hospital (HGH), Cardiac Surgical Intensive Care Unit (CICU) and Vascular Surgical Step Down Units, arterial catheters are standard of care and performed on most patients for variable periods of post-operative recovery. Within this setting, the IEEE Std 1708 and AAMI-ISO 81060-2 would be fully met. Furthermore, the cardiovascular surgical caseloads at HGH would provide sufficient test subjects to validate VitalitiTM in a timely fashion.
Interventions
DEVICEVitaliti
Measurements recorded by the Vitaliti device will be compared to the recordings from the arterial catheter.
Sponsors
Federal Economic Development Agency for Southern Ontario (FedDev Ontario)
Population Health Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Vitaliti Continuous Vital Sign Monitoring Device - Version 2.0
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients ≥18 years of age; 2. Patient has undergone major cardiac or vascular surgery and has been admitted post-op to the cardiac surgical intensive care unit (CICU) or vascular surgery step down unit with an arterial line in place
Exclusion criteria
1. Patients \< 18 years of age; 2. Pregnant; 3. Current arrhythmia 4. Blood pressure outside of test range for phase (refer to table 1) 5. Allergy to device contact adhesive (e.g. ECG leads)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure | 30 minutes | Determining the accuracy of non-invasive blood pressure measurement compared to invasive blood pressure. A detailed analysis will be conducted on the invasive blood pressure to verify accuracy as defined in the ISO 81060-2 Standard. |
Countries
Canada
Outcome results
None listed