Myocardial Injury and Intraoperative Tissue Oximetry in Patients Undergoing Spine Surgery (MONITOR)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- High-sensitivity Troponin T elevation
研究概览
简要总结
Myocardial injury after non-cardiac surgery (MINS) is common in patients undergoing major surgery. Many of the events are undetected and associated with a high 30-day mortality risk. Knowledge of which perioperative factors that predicts MINS is lacking. Decrease in tissue oxygenation (StO2) is common in patients undergoing major spine surgery and is associated with postoperative complications in these patients. However, an association between decrease in tissue oxygenation and MINS has not been examined. This group of patients may have other potential predictors of postoperative complications that the study group would like to investigate. In this observational cohort study, we will include 70 patients undergoing major spine surgery at University of California San Francisco. The primary hypothesis is that decrease in intraoperative tissue oxygenation is associated with postoperative myocardial injury.
详细描述
Significance:
Each year 10 million people worldwide suffer from myocardial injury after non-cardiac surgery (MINS). The majority of these events are undetected because they are asymptomatic and there is sparse knowledge about triggering causes. Major surgery is associated with a high risk of postoperative complications. These include covert stroke, myocardial injury and -infarction, and are all major contributors to mortality. The 30-day post-operative mortality in patients suffering from covert stroke is increased up to eight-fold compared with matched controls and is 10% in patients with MINS, which makes it a substantial public health problem. Approximately 33% of patients undergoing major spine surgery suffer from major postoperative complications, including stroke and myocardial infarction. However, knowledge is lacking regarding which perioperative factors predict myocardial injury and -infarction, covert and overt stroke, and mortality in high-risk patients such as those undergoing major spine surgery.
Measure of tissue oxygenation with near-infrared spectroscopy (NIRS) is non-invasive and uncomplicated. Tissue desaturation is common in spine surgery patients. Previous studies found that a decrease in tissue oxygenation (StO2) was associated with postoperative complications such as creatinine elevation, hypotension and prolonged hospitalization. However, current knowledge of how tissue oxygenation affects other clinical outcomes is lacking.
Thus, to address these knowledge gaps the investigators propose a cohort study to examine the association between tissue oxygenation and MINS in patients undergoing major spine surgery.
Methods This is a prospective observational cohort study. Participants are patients undergoing major spine surgery. Measurements include blood samples, non-invasive tissue oximetry and collection of general perioperative factors from the anesthesia machine. First measurements are made on the day of surgery and further measurements are conducted on the first two postoperative days. Secondary outcomes from medical records (e.g. 30-day mortality) are collected retrospectively.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥18 years
- •Patient is undergoing elective surgery of the spine
- •Surgery is scheduled to last ≥ 2 hours and involve instrumentation
排除标准
- •Patient is < 18 years
- •Patient is undergoing emergent or urgent surgery
- •American Society of Anesthesiologist (ASA) status > IV
- •Patient is undergoing non-instrumental surgery, such as laminectomy alone
- •Patient is undergoing spine surgery for tumor or infection
结局指标
主要结局
High-sensitivity Troponin T elevation
时间窗: Measurement done on first and second day after surgery (highest value of the two is used in the primary analysis)
Peak value (the highest of two postoperative measurements) of high-sensitivity Troponin T (hsTnT) elevation (as assessment for myocardial injury).
次要结局
- Myocardial injury after non-cardiac surgery (MINS)(Baseline prior to surgery (for adjustment), first and second day after surgery.)