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.
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
hearing aid(s) or cochlear implant(s) in left ear;
pacemaker/implantable cardioverter-defibrillator (ICD);
externally programmable cerebrospinal fluid shunt;
deep brain stimulator;
Patients 65 years of age and older undergoing non-cardiac surgery with anesthesia expected to require an expected length of hospital stay of 3 or more days
Cohort
Prospective
Continuous vital signs measurement device
DeviceIn 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 physiological precursors to outcome events. This data will be used to inform machine learning algorithms for prediction and early detection of post-surgical complications. A biobank will also be established to support exploratory proteomic and genotyping analyses to better understand biological mechanisms underlying post-operative complications.
Myocardial injury after noncardiac surgery (MINS)
MINS not meeting 4th definition of MI is an elevated troponin measurement that occurs during the first 30 days after surgery that is judged as resulting from myocardial ischemia AND does not fulfill the MI definition. The following defines elevated troponin measurement for the diagnosis of MINS during the first 30 days after surgery: non high sensitivity Troponin T assay: ≥0.03 µg/L; high sensitivity Troponin T assay: between 20 - \<65 ng/L with an absolute change ≥5 ng/L or a value ≥65 ng/L; DVIA Centaur Siemens high-sensitivity cardiac troponin I: ≥75 ng/L; ARCHITECT STAT Abbott Laboratories high-sensitivity cardiac troponin I ≥60 ng/L; other troponin assays: any measurement above the 99th percentile of the upper reference limit.
Bleeding independently associated with mortality after noncardiac surgery (BIMS)
A bleeding meeting any of the following 3 criteria: a) leading to a postoperative hemoglobin \<70 g/L; b) requiring transfusion of one or more units of red blood cells; c) judged to be the immediate cause of death
Sepsis
Based on the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) criteria, sepsis will require a quick Sequential Organ Failure Assessment (qSOFA) Score ≥2 points due to infection. The qSOFA includes the following items and scoring system: a) Glasgow Coma Scale (GCS) score of 13 or less (1 point); b) systolic blood pressure of 100 mm Hg or less (1 point); and c) respiratory rate of 22 breaths/min or more (1 point).
Infection without sepsis
Pathologic process caused by the invasion of normally sterile tissue or fluid or body cavity by pathogenic or potentially pathogenic organisms.
All-cause mortality
Death by any cause
Vascular mortality
Any death with a vascular cause and includes those deaths following a myocardial infarction, cardiac arrest, stroke, cardiac revascularization procedure (i.e., percutaneous coronary intervention \[PCI\] or coronary artery bypass graft \[CABG\] surgery), heart failure, pulmonary embolus, cardiovascular hemorrhage (i.e., hemorrhage causing cardiac tamponade, non-traumatic vascular rupture \[e.g., aortic aneurism, cerebrovascular aneurism\], non-stroke intracranial hemorrhage), or deaths due to an unknown cause.
Myocardial infarction (MI)
The definition of myocardial infarction follows the 4th universal definition
Stroke
An acute episode of neurological dysfunction consistent with an ischemic or hemorrhagic cause. For the diagnosis of stroke, the following criteria must be fulfilled: a) rapid onset of a focal/global neurologic deficit with at least one of the following: change in level of consciousness, hemiplegia, hemiparesis, numbness or sensory loss affecting one side of the body, dysphagia/aphasia, hemianopia, amaurosis, or other new neurological signs/symptoms consistent with stroke; b) the duration of a focal/global neurologic deficit is at least 24 hours, OR the neurological deficit results in death, OR there is neuroimaging evidence of a new infarct/ hemorrhage; and c) there is no other readily identifiable non-stroke cause for the clinical presentation (e.g., brain tumor, trauma, infection, hypoglycemia, peripheral lesion).
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Hamilton Health Sciences Corporation
Lead sponsor
McMaster University
Collaborator
Canadian Institutes of Health Research (CIHR)
Collaborator
Population Health Research Institute
Collaborator
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