Vascular Events In Patients Undergoing Same-day Noncardiac Surgery (VALIANCE) Study
- Conditions
- Surgery--ComplicationsPreoperative CareMyocardial Infarction
- Registration Number
- NCT04973397
- Lead Sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 15000
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Unplanned healthcare utilization 90 days the number of patients who have at least one of the following: unplanned admission after surgery, unplanned outpatient visit, emergency room visit and rehospitalization after same-day surgery
- Secondary Outcome Measures
Name Time Method stroke 90 days the number of patients who experience a stroke
transient ischemic attack 90 days the number of patients who experience a transient ischemic attack
coronary revascularization 90 days the number of patients who undergo coronary revascularization
unplanned admission 90 days the number of patients who have to be admitted to the hospital after undergoing a surgery planned as same-day
major postoperative and life-threatening bleeding 90 days the number of patients who experience a major postoperative and/or life-threatening bleeding
re-hospitalization 90 days the number of patients who have to be readmitted to the hospital after being discharged home following their same-day surgery
myocardial injury after noncardiac surgery (MINS) 90 days the number of patients who experience a MINS
non-fatal cardiac arrest 90 days the number of patients who experience a non-fatal cardiac arrest
unplanned outpatient visit 90 days the number of patient who had a medical visit in an outpatient setting after undergoing same-day surgery
emergency room visit 90 days the number of patients who visited the emergency room without subsequent hospitalization after undergoing same-day surgery
major cardiovascular complications 90 days the number of patients who have at least one of the following: myocardial injury or infarction, non-fatal cardiac arrest, coronary revascularization, stroke, transient ischemic attack, new clinically significant arrythmia, congestive heart failure, unplanned postoperative admission for vascular reasons, emergency room visit for vascular reasons, rehospitalization for vascular reasons, and all-cause mortality
myocardial infarction 90 days the number of patients who experience a myocardial infarction
new clinically important arrythmia 90 days the number of patients who experience a new clinically important arrythmia
deep vein thrombosis 90 days the number of patients who experience a deep vein thrombosis
pulmonary embolism 90 days the number of patients who experience a pulmonary embolism
acute congestive heart failure 90 days the number of patients who experience an acute congestive heart failure episode
postoperative infection 90 days the number of patients who experience a postoperative infection
quality of life score on the 5-level EQ-5D version (EQ-5D-5L) questionnaire 90 days score on the EQ-5D-5L questionnaire on 4 health profiles (level 1 to 5), overall self-rated health status (0-100 visual analogue scale), and EQ-5D-5L index value (0.01-0.99)
functional capacity score on the Duke Activity Status Index (DASI) 90 days change in the score on the Duke Activity Status Index (DASI) questionnaire (0 to 58.2 points)
frailty 90 days change in the level on the Clinical Frailty Scale (level 1 to 9)
acute kidney injury 90 days the number of patients who experience a acute kidney injury
Trial Locations
- Locations (14)
St-Micheal's Hospital
🇨🇦Toronto, Ontario, Canada
Wake Forest Baptist Medical Centre
🇺🇸Winston-Salem, North Carolina, United States
Cleveland Clinic Foundation Fairview Campus
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic Foundation Main Campus
🇺🇸Cleveland, Ohio, United States
St-Joseph's Healthcare Hamilton
🇨🇦Hamilton, Ontario, 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, Canada
Toronto Western Hospital
🇨🇦Toronto, Ontario, Canada
Centre Hospitalier de l'Université de Montréal (CHUM)
🇨🇦Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Sherbrooke
🇨🇦Sherbrooke, Quebec, Canada
Maasstad Ziekenhuis Rotterdam
🇳🇱Rotterdam, Netherlands
Hospital Clinic Barcelona
🇪🇸Barcelona, Spain