Evaluating The Cardiovascular Effects of Tourniquet Application
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Cardiac Cycle Efficiency (CCE), which measured with the MostCare (Vytech, Vygon, Padua, Italy) device employing the Pressure Recording Analytic Method (PRAM).
研究概览
简要总结
The goal of this prospective observational study is to investigate the impact of tourniquet application on cardiac efficiency through the cardiac cycle efficiency parameter and to explore how central regional technique alters this effect compared to general anesthesia.
We aim to answer the following main questions: 1) Does the use of a tourniquet reduce cardiac efficiency? 2) Does the impact of tourniquet use on cardiac efficiency vary with general anesthesia or central regional technique? The patients included in the study will be divided into two groups based on whether they receive general anesthesia or combined spinal epidural anesthesia.The patients' cardiac cycle efficiency and advanced hemodynamic monitoring parameters will be recorded during procedure.
详细描述
After obtaining ethical committee approval (ATADEK; 2022-14/12), 43 patients undergoing elective unilateral total knee arthroplasty under tourniquet were enrolled in our prospective observational study. Patients were divided into two groups: general anesthesia (Group GA: 22 patients) or combined spinal epidural anesthesia (Group CSEA: 21 patients). Cardiac and vascular parameters were recorded using the new algorithmic application of arterial wave analysis called Pressure Recording Analytical Method (PRAM) at 9 time points: (T1) pre-anesthesia, (T2) post-anesthesia before tourniquet inflation, (T3-8) during tourniquet inflation, and (T9) after tourniquet deflation.
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
- 是
入选标准
- •Planned for Elective Unilateral Total Knee Arthroplasty Under Tourniquet Application
- •Aged 18 and over
- •Either general anesthesia (GA) or combined spinal-epidural anesthesia (CSEA) will be administered
排除标准
- •Patients under 18 years of age
- •Patients with heart failure
- •Patients with valve disease
- •Patients with rhythm disorders
- •Patients with a history of myocardial infarction in the last 3 months
- •Patients unwilling to provide consent
结局指标
主要结局
Cardiac Cycle Efficiency (CCE), which measured with the MostCare (Vytech, Vygon, Padua, Italy) device employing the Pressure Recording Analytic Method (PRAM).
时间窗: 1 minute before and 10 minutes after anesthesia induction, 10-2-30-60 minutes after tourniquet inflation, 1 minute before tourniquet deflation, 1 minute and 5 minutes after tourniquet deflation
The CCE value must be less than 1. Approaching zero or falling to a negative value indicates a decrease in cardiac efficiency and activation of the myocardial compensation mechanisms. The PRAM minimises artefacts and data variability in patients with haemodynamic instability with its high resolution by acquiring 1000 data per second. The CCE parameter, which we utilized to assess the impact of tourniquet application on cardiac efficiency, was measured at the following time points: 1 minute before anesthesia induction (T1), 10 minutes after anesthesia induction, which is 1 minute before tourniquet inflation (T2), 10 minutes after tourniquet inflation (T3), 20 minutes after tourniquet inflation (T4), 30 minutes after tourniquet inflation (T5), 60 minutes after tourniquet inflation (T6), 1 minute before tourniquet deflation (T7), 1 minute after tourniquet deflation (T8), and 5 minutes after tourniquet deflation (T9).
次要结局
未报告次要终点
研究者
Merve Şeker
Principal Investigator
Acibadem University