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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15,000
- 试验地点
- 16
- 主要终点
- Unplanned healthcare utilization
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Unplanned healthcare utilization
时间窗: 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
次要结局
- transient ischemic attack(90 days)
- coronary revascularization(90 days)
- unplanned admission(90 days)
- stroke(90 days)
- major postoperative and life-threatening bleeding(90 days)
- re-hospitalization(90 days)
- myocardial injury after noncardiac surgery (MINS)(90 days)
- non-fatal cardiac arrest(90 days)
- unplanned outpatient visit(90 days)
- emergency room visit(90 days)
- major cardiovascular complications(90 days)
- myocardial infarction(90 days)
- new clinically important arrythmia(90 days)
- deep vein thrombosis(90 days)
- pulmonary embolism(90 days)
- acute congestive heart failure(90 days)
- postoperative infection(90 days)
- quality of life score on the 5-level EQ-5D version (EQ-5D-5L) questionnaire(90 days)
- functional capacity score on the Duke Activity Status Index (DASI)(90 days)
- frailty(90 days)
- acute kidney injury(90 days)