Myocardial Infarction, Preoperative Care, Surgery--Complications
Conditions
Keywords
Preoperative Care, Surgery, Postoperative complications, Same-day surgery, Ambulatory surgery, Outpatient 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.
Interventions
None listed
Sponsors
Centre hospitalier de l'Université de Montréal (CHUM)
Canadian Institutes of Health Research (CIHR)
Université de Montréal
Fonds de la Recherche en Santé du Québec
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| acute kidney injury | 90 days | the number of patients who experience a acute kidney injury |
| major postoperative and life-threatening bleeding | 90 days | the number of patients who experience a major postoperative and/or life-threatening bleeding |
| 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 |
| new clinically important arrythmia | 90 days | the number of patients who experience a new clinically important arrythmia |
| postoperative infection | 90 days | the number of patients who experience a postoperative infection |
| acute congestive heart failure | 90 days | the number of patients who experience an acute congestive heart failure episode |
| deep vein thrombosis | 90 days | the number of patients who experience a deep vein thrombosis |
| unplanned admission | 90 days | the number of patients who have to be admitted to the hospital after undergoing a surgery planned as same-day |
| 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 |
| 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 |
| 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 injury after noncardiac surgery (MINS) | 90 days | the number of patients who experience a MINS |
| myocardial infarction | 90 days | the number of patients who experience a myocardial infarction |
| non-fatal cardiac arrest | 90 days | the number of patients who experience a non-fatal cardiac arrest |
| coronary revascularization | 90 days | the number of patients who undergo coronary revascularization |
| 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) |
| pulmonary embolism | 90 days | the number of patients who experience a pulmonary embolism |
| frailty | 90 days | change in the level on the Clinical Frailty Scale (level 1 to 9) |
Countries
Canada, Netherlands, Spain, United States
Contacts
CONTACTMelodie Fanay Boko, MSc
PRINCIPAL_INVESTIGATOREmmanuelle Duceppe, MD, PhD
Centre Hospitalier de l'Universite de Montreal (CHUM)
Outcome results
None listed