VERDICT-2 is a device verification study which will examine examine the accuracy of the Cloud DX Vitaliti Continuous Vital Signs Monitor (Model: CVSM-1A) in an ambulatory context with healthy participants.
The objective is to determine the accuracy of continuous noninvasive vital signs metrics including respiration, pulse rate, oxyhemoglobin saturation (SpO2), core temperature, heart rate, and continuous non-invasive blood pressure (cNIBP) against standard comparator devices guided by consensus standards.
Michael McGillion is Associate Professor, and Assistant Dean, Research, at the School of Nursing, McMaster University. He is the Heart and Stroke Foundation/Michael G. DeGroote Endowed Chair in Cardiovascular Nursing Research, and the International Visiting Professor of Digital Health, at Coventry University in the UK.
He is an internationally-recognized researcher in the area of persistent forms of cardiac pain such as refractory angina and unrelieved chest pain following successful revascularization procedures. He was Chair of the Joint Canadian Cardiovascular Society – Canadian Pain Society guidelines for the management of refractory angina, funded by the Canadian Institutes of Health Research (CIHR). He is Principal Investigator of the largest CIHR-funded, international prospective cohort study to examine social and psychological predictors of chronic post-surgical pain following cardiac surgery. His research focuses on remote automated monitoring and virtual recovery support for people recovering from cardiac and vascular surgery, decision support for people living with RFA, and global-scale, web-based dissemination of new evidence on persistent forms of cardiac pain.
Mike has been recognized for his research and advocacy by receiving the Canadian Pain Society Early Career Award and the McMaster University Arch Award for outstanding contributions to society; and was the first University Scholar (2019) from the McMaster School of Nursing.
Maura Marcucci is a scientist in the Perioperative and Surgery research group at PHRI, and an Assistant Professor, Department of Medicine, and Department of Health Research Methods, Evidence, and Impact, at McMaster University. Leveraging on her background in vascular medicine, thrombosis and hemostasis disorders, and geriatrics, Maura’s current main focus of clinical research is cardiovascular and neurocognitive outcomes in noncardiac surgery. She is currently the project officer of the PeriOperative ISchemic Evaluation (POISE)-3 trial and principal investigator of the POISE-3 sub-study on delirium and cognitive decline.
She obtained her medical training and residency in Internal Medicine in Italy. In 2012-2013 she completed an MSc in Health Research Methodology and a clinical fellowship in Hematology/Medicine at McMaster University. In 2014-2016 she was an Assistant Professor at the University of Milan in Italy, before returning to Hamilton, Canada.
Carley Ouellette is a PhD student at McMaster University, School of Nursing studying under the supervision of Dr. Michael McGillion (committee: Drs. Maura Marcucci; Sandra Carroll) and is a registered nurse working clinically in the Emergency Department, Juravinski Hospital, Hamilton Health Sciences.
Carley’s research focus is on digital health innovations, wearable technologies, and virtual care with remote patient monitoring. Carley is currently leading with Drs McGillion and Marcucci, the VERDICT-2 study partnering with Cloud DX to complete a verification and user-testing study using the Vitaliti continuous vital signs monitor. This study will include a sample of patients who have undergone surgery, their caregivers, nurses, and physicians.
Carley is also the Nursing Project Officer for the PVC-RAM 1,3, and SMArTVIEW studies.
Associate Program Manager
Valerie Harvey is an Associate Program Manager with more than 12 years’ experience in clinical research at PHRI. She currently coordinates and manages interventional trials and observational studies in Digital Health in the areas of perioperative medicine and cardiac surgery. She holds a Bachelor of Science Degree (Honours) in Biological Sciences from Brock University.
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