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NCT04973397Recruiting

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

Centre hospitalier de l'Université de Montréal (CHUM)

Start Date

11/17/2021

Completion Date

4/1/2027

Summary

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.

Detailed 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.

Eligibility Criteria

Age Range: 45 years to No maximum

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.

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Conditions

Preoperative CareSurgery--ComplicationsMyocardial Infarction

Locations

Wake Forest Baptist Medical Centre

Winston-Salem, North Carolina 27157

United States

Cleveland Clinic Foundation Fairview Campus

Cleveland, Ohio 44111

United States

Cleveland Clinic Foundation Main Campus

Cleveland, Ohio 44195

United States

MD Anderson Cancer Center

Houston, Texas 77030

United States

Memorial Hermann Texas Medical Center UT Health

Houston, Texas 77030

United States

St-Joseph's Healthcare Hamilton

Hamilton, Ontario L8N 4A6

Canada

Hamilton General Hospital

Hamilton, Ontario

Canada

Juravinski Hospital and Cancer Centre

Hamilton, Ontario

Canada

McMaster University Medical Centre

Hamilton, Ontario

Canada

Mount Sinai Hospital

Toronto, Ontario M5G 1X5

Canada

Toronto Western Hospital

Toronto, Ontario M5T 2S8

Canada

St-Micheal's Hospital

Toronto, Ontario

Canada

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec H2X0C1

Canada

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec

Canada

Maasstad Ziekenhuis Rotterdam

Rotterdam,

Netherlands

Hospital Clinic Barcelona

Barcelona,

Spain