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Vitaliti Verification

Official Title

VERification study of the Cloud-DX Vitaliti™continuous automated non-invasive blood pressure monitor

Status

Ongoing

Overview

Cloud-DX Vitaliti™ is a groundbreaking new low profile automated vital sign monitor which includes a continuous non-invasive blood pressure measurement system, 2-Lead ECG (sampled at 500 Hz), heart rate and heart rate variability, respiration rate, temperature (infrared sensor in ear sampled at 20 Hz), blood oxygen saturation (Red, IR, and Green channels sampled at 200 Hz), and pulse wave velocity. Study population of 60 patients undergoing cardiac or vascular surgery, with arterial line.

Study Design

Multi-centre, blinded, randomized controlled trial

Primary Endpoint

Verification of VITALITI device’s compliance with the regulatory standards of Electrical and Electronics Engineers (IEEE) and the American Safety in Medical Technology (AAMI-ISO)

Number of Patients

50

Number of Sites

1

Number of Countries

1

Study Period

2017-2018

Principal Investigator

Michael McGillion, PJ Devereaux

Program Manager

Shirley Pettit

Research Coordinator

Amber Good