Analysis of Intra-abdominal Pressure and Trendelenburg Position Effect on Dynamic Indices of Arterial Pressure Waveform
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- dP/dt
研究概览
简要总结
Intraoperative fluid management is key component of care for patients undergoing surgery. Hypovolemia and hypervolemia both associate with increased morbidity, length of stay in the intensive care unit and mortality. Thus, maintaining adequate intravascular volume yet avoiding fluid overload is crucial to achieve optimal outcomes. Goal-directed fluid therapy based on arterial pressure waveform analysis is widely used for intraoperative fluid management and have been shown to improve surgical outcomes compared with conventional clinical assessment in several studies. However, dynamic indices of arterial pressure waveform analysis such as pulse pressure variation (PPV) and stroke volume variation (SVV) are altered by certain situations including elevated intra-abdominal pressure and Trendelenburg position. Intravascular fluid status might thus be misinterpreted. Carbon dioxide pneumoperitoneum with increased intra-abdominal pressure and Trendelenburg position are commonly seen in laparoscopic surgeries including colorectal, gynecological, and genitourinary procedures. Understanding how dynamic indices change in these clinical situations are essential for achieving appropriate intraoperative fluid management. This study focus on identifying the effects of different levels of intra-abdominal pressure and angles of Trendelenburg position on dynamic indices of arterial pressure waveform.
详细描述
In this prospective observational study, the investigators will enroll 100 patients undergoing laparoscopic surgery for medical reason. Anesthetic management and surgery will be performed as usual clinical practice.
The investigators will record the digital data exported from standard monitoring instruments, including electrocardiography, photo-plethysmography , blood pressure, neurological system information (Bispectral index and Density spectral array ), the respiratory gas monitoring (gas analyzer and respiratory waveform) and dynamic indices of arterial pressure waveform analysis (cardiac index, stroke volume variation, pulse pressure variation, hypotension prediction index... etc.) from HemoSphere advanced monitoring platform with Acumen Hypotension Prediction Index Software (Edwards Lifesciences) every 20 seconds.
After anesthesia induction as routine clinical practice, slow IV fluid infusion will be maintained. The patient will be placed in Trendelnburg position with different angles ranging from 0-25 degree. CO2 pneumoperitoneum will be created by surgeons for laparoscopic surgery. Changes in levels of intra-abdominal pressure and angles of Trendelenburg position will be recorded. The recording is ended after emergence when surgery ends. All physiological data and demographic data will be stored in digital media after being de-linked from personal identification.
Data analysis and Statistics will be particularly performed to explore the effects of levels of intra-abdominal pressure and angles of Trendelenburg position on dynamic indices of arterial pressure waveform. Methods including signal processing, modeling, classification will be used.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 20 and 80
- •Scheduled for laparoscopic surgery
- •American Society of Anesthesiologists (ASA) physical status I to III.
排除标准
- •Neurologic or behavioral disorders
- •American Society of Anesthesiologists (ASA) physical status ≥ IV
- •History of arrhythmia
- •Drug abuse or alcoholism
- •Resting room air SpO2 < 90%.
结局指标
主要结局
dP/dt
时间窗: Dynamic indices recorded starting after anesthesia induction, and stopped after emergence when surgery ends
dP/dT (mmHg/second)is the change of left ventricular pressure over time during isovolemic contraction. It is usually used as a predictor of myocardial contractility.
Hypotension Prediction Index (HPI)
时间窗: Dynamic indices recorded starting after anesthesia induction, and stopped after emergence when surgery ends
The Hypotension Prediction Index (HPI) is a prediction model based on features of arterial pressure waveform. It represents as unitless number from 1 to 100. Greater number suggested higher risk of a hypotension event occurring in the future. HPI will be obtained and recorded from HemoSphere advanced monitoring platform with Acumen Hypotension Prediction Index Software (Edwards Lifesciences).
Stroke volume variation (SVV)
时间窗: Dynamic indices recorded starting after anesthesia induction, and stopped after emergence when surgery ends
SVV is the ratio of the maximum (SVmax) SV minus the minimum SV (SVmin) to the mean SV (SVmean), averaged over several respiratory cycles. SVV is an indicator of a patient's position on the Frank-Starling Curve. Studies suggested SVV \>10 % is associated with fluid responsiveness. SVV will be obtained and recorded from HemoSphere advanced monitoring platform with Acumen Hypotension Prediction Index Software (Edwards Lifesciences).
Pulse pressure variation (PPV)
时间窗: Dynamic indices recorded starting after anesthesia induction, and stopped after emergence when surgery ends
PPV is the ratio of the maximum pulse pressure (systolic blood pressure minus diastolic blood pressure; PPmax) minus the minimum pulse pressure (PPmin) to the mean pulse pressure (PPmean), averaged over several respiratory cycles. PPV is an indicator of a patient's position on the Frank-Starling Curve. Studies suggested PPV \>13-15 %is associated with fluid responsiveness. PPV will be obtained and recorded from HemoSphere advanced monitoring platform with Acumen Hypotension Prediction Index Software (Edwards Lifesciences).
Dynamic arterial elastance (Eadyn)
时间窗: Dynamic indices recorded starting after anesthesia induction, and stopped after emergence when surgery ends
Dynamic arterial elastance (Eadyn) is the ratio of pulse pressure variations (PPV) to stroke volume variations (SVV). Studies have shown Eadyn as a predictor of blood pressure response to fluid resuscitation in hypotension, fluid-responsive patients. Eadyn will be obtained and recorded from HemoSphere advanced monitoring platform with Acumen Hypotension Prediction Index Software (Edwards Lifesciences).
次要结局
- Bispectral index (BIS) value(BIS monitor are recorded starting from anesthesia induction, and stopped after emergence when surgery ends)