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

NCT03493867 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2020-03-03

No results posted yet for this study

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

Interventions

DEVICE

Vitaliti

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

Sponsors & Collaborators

  • Federal Economic Development Agency for Southern Ontario (FedDev Ontario)

    collaborator OTHER

  • Population Health Research Institute

    lead OTHER

Principal Investigators

  • Michael McGillion, RN, PhD · School of Nursing, Faculty of Health Sciences, McMaster University

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-09
Primary Completion
2019-11-06
Completion
2019-11-06

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03493867 on ClinicalTrials.gov