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Digital Health

VISION-2

Vascular Events in Noncardiac Surgery Patients - 2
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VISION-2 is an international, multi-site, prospective observational cohort study of 20,000 adult participants (aged 65 or older) who have undergone noncardiac surgery.

Major postoperative complications and deaths predominantly occur after patients leave the operating room, often in settings with limited or no continuous vital signs monitoring. Traditional intermittent vital‑sign assessments (every 4–12 hours in hospital and none after hospital discharge) may fail to detect early physiologic deterioration. Continuous, multiparameter physiologic monitoring offers the opportunity to identify biophysical signal patterns that precede serious postoperative complications.

Study procedures:

  • The Vitaliti™ continuous vital signs monitor will continuously collected pulse oximetry, respiration rate, heart rate, core body temperature, non-invasive blood pressure (NiBP), and high-fidelity biometric signals (i.e. 5-lead ECG and photoplethysmography), 24-hours a day, in hospital, and into the home setting for up to 30 days after surgery.
  • Blood samples will be collected preoperatively and postoperatively while in hospital.
  • Participants will be followed during their hospital stay and contacted at 30 days and 1 year after surgery to ascertain study outcomes.
  • Participants, clinicians, research personnel and outcome adjudicators will be blinded to device-derived data.

Primary objectives of the study:

  • Characterize the pattern and frequency of physiological precursors to:
    – Myocardial injury after noncardiac surgery (MINS)
    – Bleeding independently associated with mortality after noncardiac surgery (BIMS)
    – Sepsis
    – Infection without sepsis
  •  Develop supervised machine‑learning prediction models using continuous biometric signals for early detection of these complications.
  • Establish a perioperative biobank to support discovery and evaluation of novel biomarkers.

 

Study Type

Observational

Study Design

Prospective cohort

NO. of Countries

10-15

NO. of Sites

20-30

NO. of Participants

20000

Study Period

2026-2030

Sponsor

PHRI

Key Team Members

PJ Devereaux

Deputy Director, Senior Scientist

PJ Devereaux
Deputy Director, Senior Scientist
PJ.Devereaux@phri.ca

Devereaux is a cardiologist, perioperative care physician, and clinical epidemiologist. He is the Director of the Division of Perioperative Care at McMaster University and a Deputy Director, Senior Scientist, and Scientific Leader of the Anesthesiology, Perioperative Medicine, and Surgical Research Group at PHRI. He is the Nominated Principal Applicant of the Accelerating Clinical Trials (ACT) Consortium, which is the Pan-Canadian Clinical Trials Consortium funded by the Canadian Institutes of Health Research (CIHR). Additionally, he holds a Tier 1 Canadian Research Chair in Perioperative Medicine.

Devereaux is a full Professor at McMaster University and the President of the Society of Perioperative Research and Care. He has published over 450 peer-reviewed papers and more than 85 book chapters, editorials, and commentaries, including 17 in the New England Journal of Medicine, 13 in the Lancet, and 11 in JAMA. He has an h-index of 115 and has given over 1000 lectures and research presentations in 41 countries. His research program focuses on major vascular complications during and after surgery, and he has led many large international randomized trials and prospective cohort studies on this topic.

Michael McGillion

Scientist

Michael McGillion
Scientist
Michael.McGillion@phri.ca

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.

Sandra Ofori

Scientist

Sandra Ofori
Scientist
sandra.ofori@phri.ca

Sandra Ofori is a Scientist in the Perioperative and Surgery research group at PHRI, an Assistant Professor in McMaster University’s Department of Medicine (cardiology), and a general cardiologist in Hamilton Health Sciences and St Joseph’s hospital, Hamilton. Her research interests are in the areas of perioperative care and cardiovascular disease prevention.

Her current research program is focused on optimizing the health of patients undergoing surgery with a focus on perioperative smoking cessation and secondary prevention strategies. Ofori is actively involved in the conduct of large international perioperative clinical trials coordinated from PHRI and was the project officer of the Post Discharge after Surgery Virtual Care with Remote Automated Monitoring Technology (PVC-RAM) 1 and 3 trials and a Co-Investigator in the PVC-RAM-2 trial. She is leading the smoking cessation program in the perioperative care group and is the Co-PI of the PREVENT trial.

Ofori completed her residency training in Internal Medicine and Cardiology at the University of Port Harcourt, Nigeria. She holds a Master’s degree in Preventive Cardiology from the Imperial College, London UK, and completed a Perioperative Medicine fellowship and a PhD in Health Research Methodology (Clinical Epidemiology) from McMaster University both under the supervision of PHRI Senior Scientist PJ Devereaux. She was in the third cohort of the World Heart Federation Salim Yusuf Emerging Leaders Program that was focused on the reduction of the global burden of hypertension

Jessica Tyrwhitt

Program Director

Jessica Tyrwhitt
Program Director
Jessica.Tyrwhitt@phri.ca

Jessica Tyrwhitt has more than 10 years’ experience in coordinating and managing large, international clinical trials. She oversees interventional trials, registries, and observational research studies looking at primary and secondary prevention of cardiovascular disease in a variety of therapeutic areas, including cardiology, thrombosis, nephrology, cardio-oncology and diabetes.

She holds an Honours Bachelor of Science Degree & Business from the University of Waterloo.

 

Valerie Harvey

Associate Program Manager

Valerie Harvey
Associate Program Manager
valerie.harvey@phri.ca

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.

Carley Ouellette

Research Fellow

Carley Ouellette
Research Fellow
carley.ouellette@phri.ca

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.

Partners, Collaborators, and Supporters

Cloud DX

Vitaliti Technologies Inc.

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