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

NCT03493867 | Completed

• 1 other identifier: STP-VIT-002
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure

Keywords

Non-invasive blood pressure monitoring; Wearable device; Medical device verification study

Outcome Measures

Primary Outcomes (1)

• Blood pressure

  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.

  30 minutes

Study Arms (1)

Vitaliti

OTHER

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.

Device: Vitaliti

Interventions

Vitaliti DEVICE

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

Vitaliti

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥18 years of age;
• 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

You may not qualify if:

• Patients \< 18 years of age;
• Pregnant;
• Current arrhythmia
• Blood pressure outside of test range for phase (refer to table 1)
• Allergy to device contact adhesive (e.g. ECG leads)

Sponsors & Collaborators

• Population Health Research Institute: lead
• Federal Economic Development Agency for Southern Ontario (FedDev Ontario): collaborator

Study Sites (1)

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

Related Publications (1)

• 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.

  PMID: 34876396 DERIVED

Study Officials

• Michael McGillion, RN, PhD

  School of Nursing, Faculty of Health Sciences, McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and Assistant Dean

Model Details: Vitaliti Continuous Vital Sign Monitoring Device - Version 2.0

Study Record Dates

• First Submitted: March 16, 2018
• First Posted: April 11, 2018
• Study Start: August 9, 2018
• Primary Completion: November 6, 2019
• Study Completion: November 6, 2019
• Last Updated: March 3, 2020

Record last verified: 2020-03

Locations

CA (1)