ongoing

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 collect 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

2026-2031

Sponsor

PHRI

Vitaliti Technologies Inc.

Cloud DX

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