Study Type
Observational
February 3, 2022
Ageing-in-place: Canada-EU collaboration
A new PHRI study is part of a Canada-European Union (EU) consortium to develop, test and support novel e-health solutions...
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ongoing
In this study, we will use innovative technology to collect prospective, continuous biometric data (i.e., continuous non-invasive blood pressure, 5-lead ECG, heart rate, respiratory rate, temperature, and oxygen saturation) on 20,000 patients undergoing noncardiac surgery.
The objectives of the study are to:
- Further examine the accuracy and user experience of the Cloud DX Vitaliti™ continuous vital signs monitoring device.
- Work to develop machine learning predictive models to prevent postoperative adverse events and improve outcomes for postoperative care transition.
- Establish Remote Automated Monitoring (RAM) technology proof-of-concept workflows for further applicatoins to utilize the training predictive models with patients in the real-world post-surgical environment.
- Determine feasible and optimal placement of RAM algorithms at either the point-of-care, with edge-based computing on the Vitaliti™ CVSM, or on companion mobile devices (e.g. phone, tablet) or within cloud computing infrastructure for longer-term use.
- Develop plan for validation of the machine learning models to identify model performance in terms of the timeliness of early prediction of impending adverse events.
- Determine pattern and frequency of physiologic precursors of MINS, bleeding, and sepsis.
- Derive cost estimates.
Study Design
Prospective cohort
NO. of Countries
10
NO. of Sites
30
NO. of Participants
20000
Study Period
2022 - 2026
Sponsor
PHRI
PJ Devereaux
Senior Scientist
PJ Devereaux
Senior Scientist
PJ Devereaux is Senior Scientific Lead, Perioperative and Surgery, PHRI, Professor and University Scholar in the Departments of Health Research Methods, Evidence, and Impact (HEI) and Medicine at McMaster University, and Director of the Division of Cardiology at McMaster.
The focus of his clinic research is vascular complications around the time of surgery, leading several large, international RCTs and observational studies addressing this issue. He has published more than 250 peer-reviewed papers and more than 50 book chapters and editorials. He is supported by a Tier 1 Canadian Research Chair in Perioperative Medicine, and holds the Yusuf Chair in Cardiology at McMaster University.
Michael McGillion
Scientist
Michael McGillion
Scientist
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.
Jessica Vincent
Program Director
Jessica Vincent
Program Director
Jessica Vincent has more than 15 years’ experience in coordinating and managing large, international clinical trials. As Associate Program Manager, she oversees interventional trials, registries, and observational research studies in the areas of perioperative medicine, cardiac surgery, and digital health.
She holds an Honours Bachelor of Science Degree from Queens University, and a Master of Clinical Epidemiology Degree from the University of Newcastle.
Valerie Harvey
Associate Program Manager
Valerie Harvey
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.
Cloud DX
completed
VERDICT
Digital Health
Cloud-DX Vitaliti (TM) is a groundbreaking new low-profile automated vital sign monitor which includes: A...
completed
SMARTVIEW
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SMArTVIEW is an eHealth-enabled service delivery program that combines remote automated monitoring, education, and self-management...
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PVC-RAM-1
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PVC-RAM-1 was a multicentre, parallel group, superiority, randomized controlled trial to determine the effect of...
ongoing
PVC-RAM-3
Digital Health
PVC-RAM-3 is a multicentre, parallel group, superiority, randomized controlled trial to determine the effect of...
completed
VISION
Perioperative and Surgery
The objective of the VISION study was to collect international data regarding major adverse vascular...
