Verification of The Cloud DX Vitaliti™ Continuous Vital Sign Monitor (CVSM): Non-invasive Blood Pressure Component

Not Applicable

Completed

• Conditions: Blood Pressure
• Interventions: Device: Vitaliti

• Registration Number: NCT03493867
• Lead Sponsor: Population Health Research Institute

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.

Study Timeline

• Study First Submitted: 2018-03-16
• Study First Submitted QC: 2018-04-03
• Study First Posted: 2018-04-11
• Study Start: 2018-08-09
• Primary Completion: 2019-11-06
• Study Completion: 2019-11-06
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-02
• Last Update Posted: 2020-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vitaliti	Vitaliti	The subject's blood pressure will be simultaneously determined and recorded using the invasive arterial line blood pressure reading and the test Vitaliti device readings.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Hamilton General Hospital; 🇨🇦 Hamilton, Ontario, Canada