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

NCT ID: NCT03493867

Last Updated: 2020-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-09
• Study Completion Date: 2019-11-06

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.

Conditions

Blood Pressure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Vitaliti

Intervention Type: DEVICE

Measurements recorded by the Vitaliti device will be compared to the recordings from the arterial catheter.

Interventions

Vitaliti

Measurements recorded by the Vitaliti device will be compared to the recordings from the arterial catheter.

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal Economic Development Agency for Southern Ontario (FedDev Ontario)

OTHER

Sponsor Role: collaborator

Population Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Mike McGillion

Associate Professor and Assistant Dean

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael McGillion, RN, PhD

Role: PRINCIPAL_INVESTIGATOR

School of Nursing, Faculty of Health Sciences, McMaster University

Locations

Hamilton General Hospital

Hamilton, Ontario, Canada

Countries

Canada

References

McGillion MH, Dvirnik N, Yang S, Belley-Cote E, Lamy A, Whitlock R, Marcucci M, Borges FK, Duceppe E, Ouellette C, Bird M, Carroll SL, Conen D, Tarride JE, Harsha P, Scott T, Good A, Gregus K, Sanchez K, Benoit P, Owen J, Harvey V, Peter E, Petch J, Vincent J, Graham M, Devereaux PJ. Continuous Noninvasive Remote Automated Blood Pressure Monitoring With Novel Wearable Technology: A Preliminary Validation Study. JMIR Mhealth Uhealth. 2022 Feb 28;10(2):e24916. doi: 10.2196/24916.

Reference Type: DERIVED

PMID: 34876396 (View on PubMed)

Other Identifiers

STP-VIT-002

Identifier Type: -

Identifier Source: org_study_id