Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 10:51 PM
Study NCT ID:
NCT03493867
Status:
COMPLETED
Last Update Posted:
2020-03-03
First Post:
2018-03-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Verification of The Cloud DX Vitaliti™ Continuous Vital Sign Monitor (CVSM): Non-invasive Blood Pressure Component
Sponsor:
Population Health Research Institute
Organization:
Study Overview
Official Title:
Verification Protocol for The Cloud DX Vitaliti™ Continuous Vital Sign Monitor (CVSM): Non-invasive Blood Pressure Component for Clinical Use and Self Measurement According to the American Safety in Medical Technology and the IEEE
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: