Vascular Events in Noncardiac Surgery Patients Cohort Evaluation Study 2
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20,000
- 试验地点
- 5
- 主要终点
- Myocardial injury after noncardiac surgery (MINS)
研究概览
简要总结
VISION-2 is an international, multi-site, prospective observational cohort study of 20,000 patients undergoing noncardiac surgery. Continuous biometric data will be blindly collected for the first 30 postoperative days, in hospital and at home, using Vitaliti™. Following study enrollment and baseline data collection, follow up visits will occur in-hospital, at 30-days, and 1-year post-operatively.
VISION-2 has 3 primary objectives, among participants who underwent noncardiac surgery, the investigators will: 1) determine the pattern and frequency of physiological precursors (i.e., biophysical signals) to MINS, BIMS, sepsis, and infection without sepsis; 2) build prediction models from these biophysical signals and their extracted features through supervised machine learning, for the prediction and early detection of those complications; and 3) build a biobank for evaluation of novel biomarkers.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥65 years;
- •underwent non-cardiac surgery with general, neuraxial, local, or regional anesthesia; and
- •expected length of hospital stay of 3 or more days
排除标准
- •hearing aid(s) or cochlear implant(s) in left ear;
- •pacemaker/implantable cardioverter-defibrillator (ICD);
- •externally programmable cerebrospinal fluid shunt;
- •deep brain stimulator;
- •intolerance/allergy to adhesive;
- •history of dementia, or;
- •previous enrollment in the VISION-2 Study
结局指标
主要结局
Myocardial injury after noncardiac surgery (MINS)
时间窗: 30 days after surgery
MINS not meeting 4th definition of MI is an elevated troponin measurement that occurs during the first 30 days after surgery that is judged as resulting from myocardial ischemia AND does not fulfill the MI definition. The following defines elevated troponin measurement for the diagnosis of MINS during the first 30 days after surgery: non high sensitivity Troponin T assay: ≥0.03 µg/L; high sensitivity Troponin T assay: between 20 - \<65 ng/L with an absolute change ≥5 ng/L or a value ≥65 ng/L; DVIA Centaur Siemens high-sensitivity cardiac troponin I: ≥75 ng/L; ARCHITECT STAT Abbott Laboratories high-sensitivity cardiac troponin I ≥60 ng/L; other troponin assays: any measurement above the 99th percentile of the upper reference limit.
Bleeding independently associated with mortality after noncardiac surgery (BIMS)
时间窗: 30 days after surgery
A bleeding meeting any of the following 3 criteria: a) leading to a postoperative hemoglobin \<70 g/L; b) requiring transfusion of one or more units of red blood cells; c) judged to be the immediate cause of death
Sepsis
时间窗: 30 days after surgery
Based on the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) criteria, sepsis will require a quick Sequential Organ Failure Assessment (qSOFA) Score ≥2 points due to infection. The qSOFA includes the following items and scoring system: a) Glasgow Coma Scale (GCS) score of 13 or less (1 point); b) systolic blood pressure of 100 mm Hg or less (1 point); and c) respiratory rate of 22 breaths/min or more (1 point).
Infection without sepsis
时间窗: 30 days after surgery
Pathologic process caused by the invasion of normally sterile tissue or fluid or body cavity by pathogenic or potentially pathogenic organisms.
All-cause mortality
时间窗: 30 days after surgery
Death by any cause
次要结局
- All-cause mortality(30 days after surgery)
- Vascular mortality(30 days and 1 year after surgery)
- Myocardial infarction (MI)(30 days and 1 year after surgery)
- Stroke(30 says and 1 year after surgery)
- Proximal venous thromboembolism (VTE)(30 days and 1 year after surgery)
- Proximal deep venous thrombosis (DVT)(30 days and 1 year after surgery)
- Pulmonary embolism (PE)(30 days and 1 year after surgery)
- Acute kidney injury (AKI)(30 days and 1 year after surgery)
- New acute renal failure resulting in dialysis(30 days and 1 year after surgery)
- Acute heart failure(30 days and 1 year after surgery)
- New clinically important atrial fibrillation(30 days and 1 year after surgery)
- Nonfatal cardiac arrest(30 days and 1 year after surgery)
- Life-threatening bleeding(30 days and 1 year after surgery)
- Critical organ bleeding(30 days and 1 year after surgery)
- Peripheral arterial thrombosis(30 days and 1 year after surgery)
- Amputation(30 days and 1 year after surgery)
- Delirium(30 days and 1 year after surgery)
- Pneumonia(30 days and 1 year after surgery)
- Surgical site infection(30 days and 1 year after surgery)
- Urinary tract infection(30 days and 1 year after surgery)
- Clinically important ileus(30 days and 1 year after surgery)
- Falls(30 days and 1 year after surgery)
- Post-discharge acute hospital care(30 days after surgery)
- Emergency department visit(30 days after surgery)
- Rehospitalization(30 days after surgery)
- Sepsis(1 year after surgery)
- Infection without sepsis(1 year after surgery)