Vascular Events In Patients Undergoing Same-day Noncardiac Surgery (VALIANCE) Study

Centre hospitalier de l'Université de Montréal (CHUM)

Status: Enrolling

Conditions: Preoperative Care; Surgery--Complications; Myocardial Infarction

Study type: Observational

Funder types: Other

Identifiers

NCT04973397

MP-02-2022-9889

Details and patient eligibility

About

The proportion of noncardiac surgeries performed as same-day surgery is increasing worldwide, with more complex surgeries being performed on higher risk patients in the outpatient setting. Little is known on the risk factors, incidence and prognosis of patients undergoing same-day noncardiac surgery. The main objective of this study is to inform on the incidence and risk factors of cardiovascular and other adverse events after same-day surgery and to develop risk prediction tools to better inform on the risk and selection of patients undergoing same-day surgery.

Full description

The VALIANCE Study is a 15,000 patient, multicentre, prospective observational cohort of adults undergoing elective same-day noncardiac surgery and who will be followed for 90 days after surgery. The primary objective of the study is to determine the incidence of major cardiovascular complications after same-day surgery. Patients will also be followed for the occurence of other adverse postoperative complications and determine their change in quality of life at 90 days after surgery. VALIANCE will inform on the risk factors for postoperative complications and allow to develop risk prediction tools to guide patient selection and risk stratification of patients undergoing same-day surgery. The study will also look at validating the use of the Duke Activity Status Index questionnaire, Clinical Frailty Scale, and the Revised Cardiac Risk Index. Postoperative pain will be evaluated using the Brief pain inventory score and quality of life using the EQ-5D-5L questionnaire.

Enrollment: 15,000 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 45-64 years of age with at least one risk factor, or ≥65 years of age;
• undergoing elective noncardiac same-day surgery;
• planned duration in the operating room 60 minutes or more;
• provided written consent.

Exclusion criteria

• intervention does not require the presence of an anesthesiologist;
• procedure is performed by a nonsurgical specialty (e.g., gastroenterology, pneumology, radio-oncology or radiology);
• intervention is an ophthalmologic procedure;
• previously enrolled in the VALIANCE study.