Vascular Events in Noncardiac Surgery Patients Cohort Evaluation Study 2 (VISION-2)

Hamilton Health Sciences (HHS)

Status: Not yet enrolling

Conditions: Post-operative Complications; Bleeding Independently Associated With Mortality After Noncardiac Surgery (BIMS); Infection Without Sepsis; Sepsis; Myocardial Injury After Noncardiac Surgery (MINS)

Treatments: Device: Continuous vital signs measurement device

Study type: Observational

Funder types: Other

Identifiers

NCT07300579

1.0.2025.08.25

Details and patient eligibility

About

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, we 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.

Enrollment: 20,000 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. age ≥65 years;
2. underwent non-cardiac surgery with general, neuraxial, local, or regional anesthesia; and
3. expected to require an overnight hospital admission after surgery.

Exclusion criteria

1. hearing aid(s) or cochlear implant(s) in left ear;
2. pacemaker/implantable cardioverter-defibrillator (ICD);
3. externally programmable cerebrospinal fluid shunt;
4. deep brain stimulator;
5. intolerance/allergy to adhesive;
6. history of dementia, or;
7. previous enrollment in the VISION-2 Study