Investigation of the Relationship Between Hypotension and Tissue O2 in Invasive Eadyn During Anesthesia Induction in Open Heart Surgery: Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Eadyn
研究概览
简要总结
Our aim is to identify patients who may experience hypotension during anesthesia induction. Intraoperative hemodynamic stability plays an important role in tissue oxygenation. Although the duration of hypotension can be kept short with the necessary interventions, it is important that hypotension is predictable in order to prevent intraoperative complications and postoperative organ damage.
40 patients scheduled for open heart surgery will be monitored from one minute before anesthesia is administered until ten minutes after. Patients will be divided into two groups based on the presence or absence of hypotension during the monitoring period. All patients will be monitored according to a standardized procedure. Demographic data, non-invasive and invasive hemodynamic parameters, primarily Eadyn, and cerebral and renal tissue saturation data will be collected. Moreover, vasopressor administration in response to hypotension will be recorded.
详细描述
Introduction: Hypotension during and after the induction of anesthesia is a common occurrence. Several factors may contribute to post-induction hypotension, including prolonged fasting, underlying comorbidities, sympathetic blockade induced by anesthetic agents, vasodilation, decreased preload, and reduced cardiac contractility.
Numerous studies have identified factors and predictors associated with post-induction hypotension; however, most of these predictors are non-modifiable. Previous research has shown that patients at risk for post-induction hypotension can be identified using variables such as the inferior vena cava collapsibility index, carotid intima-media thickness, pulse pressure variation (PPV), and stroke volume variation (SVV).
Nevertheless, most of these studies have focused on assessing the cardiovascular system using preload- and fluid-responsiveness-related parameters, while the interaction between the arterial system and the ventricle has often been overlooked. Dynamic arterial elastance (Eadyn), defined as the ratio between pulse pressure variation (PPV) and stroke volume variation (SVV), integrates the flow generated by the heart and the opposing pressure from the arterial system during the respiratory cycle, and has been proposed as a functional measure of arterial load.
Furthermore, recent studies suggest that post-induction hypotension is associated with arterial vasodilation rather than venous dilation or decreased myocardial contractility.
In current anesthetic practice, interventions are typically applied only after hypotension has developed. We hypothesize that if patients at risk of developing hypotension during anesthesia induction can be identified in advance, prophylactic administration of fluids and vasopressors could reduce the duration and severity of hypotension, thereby preventing potential intraoperative complications and postoperative organ dysfunction.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anaesthesiologists (ASA) Physical Status classification I to III
- •Patients who planned open heart surgery
排除标准
- •Age < 18 years
- •Presence of arrhythmia (atrial fibrillation or frequent premature beats)
- •Severe valvular heart disease (aortic or mitral stenosis/insufficiency)
- •Severe heart failure (EF < 40%)
- •Congenital heart disease
- •Severe chronic lung disease
- •Chronic kidney disease requiring dialysis
- •Severe peripheral vascular disease
- •Morbid obesity
- •Emergency surgery cases
研究组 & 干预措施
Hypotension Group
Patients whose systolic blood pressure decreased below 90 mmHg or whose mean arterial pressure dropped by more than 30% from the preinduction baseline value were classified as hypotensive
干预措施: Masimo NIRS (Device)
Hypotension Group
Patients whose systolic blood pressure decreased below 90 mmHg or whose mean arterial pressure dropped by more than 30% from the preinduction baseline value were classified as hypotensive
干预措施: Hemodynamic Measurements on Standart Monitoring (Device)
Non-hypotension Group
Patients whose systolic blood pressure remained above 90 mmHg and whose mean arterial pressure did not decrease by more than 30% from the preinduction baseline value were classified as non-hypotensive.
干预措施: Masimo NIRS (Device)
Non-hypotension Group
Patients whose systolic blood pressure remained above 90 mmHg and whose mean arterial pressure did not decrease by more than 30% from the preinduction baseline value were classified as non-hypotensive.
干预措施: Hemodynamic Measurements on Standart Monitoring (Device)
Non-hypotension Group
Patients whose systolic blood pressure remained above 90 mmHg and whose mean arterial pressure did not decrease by more than 30% from the preinduction baseline value were classified as non-hypotensive.
干预措施: mostcare hemodynamic monitor (Device)
Hypotension Group
Patients whose systolic blood pressure decreased below 90 mmHg or whose mean arterial pressure dropped by more than 30% from the preinduction baseline value were classified as hypotensive
干预措施: mostcare hemodynamic monitor (Device)
结局指标
主要结局
Eadyn
时间窗: Perioperative
Dynamic Arterial Elastance
rso2
时间窗: Perioperative
Cerebral and Kidney Regional Saturation
Intraoperative hypotension
时间窗: perioperative
Explanatory outcome
次要结局
未报告次要终点