Clinical trial NCT04973397: Vascular Events In Patients Undergoing Same-day Noncardiac Surgery (VALIANCE) Study
Official title: Vascular Events In Patients Undergoing Same-day Noncardiac Surgery (VALIANCE) Study - A Prospective Observational Cohort Study Evaluating Major Cardiovascular and Adverse Events in Patients Undergoing Elective Same-day Noncardiac Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Preoperative Care
Surgery--Complications
Myocardial Infarction
Keywords: Preoperative Care
Surgery
Postoperative complications
Same-day surgery
Ambulatory surgery
Outpatient surgery
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Université de Montréal
name: Fonds de la Recherche en Santé du Québec
First posted: 2021-07-22
Enrollment: 15000
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All eligible adults undergoing elective same-day noncardiac surgery

Brief 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: 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.

Primary outcomes:
measure: Unplanned healthcare utilization
timeFrame: 90 days
Secondary outcomes:
measure: unplanned admission
timeFrame: 90 days
measure: unplanned outpatient visit
timeFrame: 90 days
measure: emergency room visit
timeFrame: 90 days
measure: re-hospitalization
timeFrame: 90 days
measure: major cardiovascular complications
timeFrame: 90 days
measure: myocardial injury after noncardiac surgery (MINS)
timeFrame: 90 days
measure: myocardial infarction
timeFrame: 90 days
measure: non-fatal cardiac arrest
timeFrame: 90 days
measure: coronary revascularization
timeFrame: 90 days
measure: stroke
timeFrame: 90 days
measure: transient ischemic attack
timeFrame: 90 days
measure: new clinically important arrythmia
timeFrame: 90 days
measure: acute congestive heart failure
timeFrame: 90 days
measure: deep vein thrombosis
timeFrame: 90 days
measure: pulmonary embolism
timeFrame: 90 days
measure: major postoperative and life-threatening bleeding
timeFrame: 90 days
measure: postoperative infection
timeFrame: 90 days
measure: acute kidney injury
timeFrame: 90 days
measure: quality of life score on the 5-level EQ-5D version (EQ-5D-5L) questionnaire
timeFrame: 90 days
measure: functional capacity score on the Duke Activity Status Index (DASI)
timeFrame: 90 days
measure: frailty
timeFrame: 90 days
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Centre
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation Fairview Campus
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation Main Campus
state: Ohio
city: Hamilton
country: Canada
facility: St-Joseph's Healthcare Hamilton
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: Hamilton
country: Canada
facility: Juravinski Hospital and Cancer Centre
state: Ontario
city: Hamilton
country: Canada
facility: McMaster University Medical Centre
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
city: Toronto
country: Canada
facility: St-Micheal's Hospital
state: Ontario
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal (CHUM)
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
city: Rotterdam
country: Netherlands
facility: Maasstad Ziekenhuis Rotterdam
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona
Study officials:
affiliation: Centre Hospitalier de l'Universite de Montreal (CHUM)
name: Emmanuelle Duceppe, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boko MF, Khanna AK, D'Aragon F, Spence J, Conen D, Patel A, Ayad S, Wijeysundera DN, Choiniere M, Sessler DI, Carrier FM, Harlock J, Koopman JSHA, Durand M, Bhojani N, Turan A, Page G, Devereaux PJ, Duceppe E; VALIANCE Study Collaborators. Incidence and Risk Factors of Chronic Postoperative Pain in Same-day Surgery: A Prospective Cohort Study. Anesthesiology. 2024 Aug 1;141(2):286-299. doi: 10.1097/ALN.0000000000005030.