Vascular Events in Noncardiac Surgery Patients Cohort Evaluation Study 2
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Continuous vital signs measurement device.
- Who it may be relevant to
- Registry conditions: Myocardial Injury After Noncardiac Surgery (MINS), Bleeding Independently Associated With Mortality After Noncardiac Surgery (BIMS), Sepsis, Infection Without Sepsis. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
VISION-2 is an international, multi-site, prospective observational cohort study of 20,000 patients undergoing noncardiac surgery. Continuous biometric data will be blindly collected for the first 30 postoperative days, in hospital and at home, using Vitaliti™. Following study enrollment and baseline data collection, follow up visits will occur in-hospital, at 30-days, and 1-year post-operatively. VISION-2 has 3 primary objectives, among participants who underwent noncardiac surgery, the investigators will: 1) determine the pattern and frequency of physiological precursors (i.e., biophysical signals) to MINS, BIMS, sepsis, and infection without sepsis; 2) build prediction models from these biophysical signals and their extracted features through supervised machine learning, for the prediction and early detection of those complications; and 3) build a biobank for evaluation of novel biomarkers.
Interventions
- Device Continuous vital signs measurement device
In this observational study, enrolled participants will wear the Vitaliti™ CVSM-1A device continuously before surgery, wherever and whenever possible, or as soon as possible after surgery and for up to 30-days after surgery. We will collect continuous biometric data using the Vitaliti™ CVSM-1A device. Patients, healthcare providers, data collectors, and outcome adjudicators will be blind to the Vitaliti™ data. Data from participants will be analyzed to determine the pattern and frequency of phys
Primary outcome measures
- Myocardial injury after noncardiac surgery (MINS) [Time frame: 30 days after surgery]
- Bleeding independently associated with mortality after noncardiac surgery (BIMS) [Time frame: 30 days after surgery]
- Sepsis [Time frame: 30 days after surgery]
- Infection without sepsis [Time frame: 30 days after surgery]
Secondary outcome measures (12)
- All-cause mortality [Time frame: 30 days after surgery]
- Vascular mortality [Time frame: 30 days and 1 year after surgery]
- Myocardial infarction (MI) [Time frame: 30 days and 1 year after surgery]
- Stroke [Time frame: 30 says and 1 year after surgery]
- Proximal venous thromboembolism (VTE) [Time frame: 30 days and 1 year after surgery]
- Proximal deep venous thrombosis (DVT) [Time frame: 30 days and 1 year after surgery]
- Pulmonary embolism (PE) [Time frame: 30 days and 1 year after surgery]
- Acute kidney injury (AKI) [Time frame: 30 days and 1 year after surgery]
- New acute renal failure resulting in dialysis [Time frame: 30 days and 1 year after surgery]
- Acute heart failure [Time frame: 30 days and 1 year after surgery]
- New clinically important atrial fibrillation [Time frame: 30 days and 1 year after surgery]
- Nonfatal cardiac arrest [Time frame: 30 days and 1 year after surgery]
Eligibility criteria
Inclusion criteria
- age ≥65 years;
- underwent non-cardiac surgery with general, neuraxial, local, or regional anesthesia; and
- expected length of hospital stay of 3 or more days
Exclusion criteria
- hearing aid(s) or cochlear implant(s) in left ear;
- pacemaker/implantable cardioverter-defibrillator (ICD);
- externally programmable cerebrospinal fluid shunt;
- deep brain stimulator;
- intolerance/allergy to adhesive;
- history of dementia, or;
- previous enrollment in the VISION-2 Study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Canada · 3 centers
- Hamilton General Hospital — Hamilton
- St. Joseph's Healthcare Hamilton — Hamilton
- Juravinski Hospital & Cancer Centre — Hamilton
Identifiers
NCT: NCT07300579 · 1.0.2026.01.13