Is Regional Oxygen Saturation Effective in Predicting Perfusion Parameters and Patient Outcomes in Liver Resection
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Hepatic and renal tissue oxygenation
研究概览
简要总结
Sudden hypotension, which may develop during liver resection operations performed under general anesthesia, can affect the patient satisfaction at a high rate by causing complications during and after the operation as a result of disrupting the blood supply of the tissues. Although there are standard monitoring methods such as blood pressure, heart rate, and oxygen status that show unwanted hypotension during anesthesia, it is possible to show hypotension in the early period with new generation methods. Although there are many clinical studies proving the effectiveness of these methods, these methods have not yet been included in the standard monitoring methods.
Our prediction in this study is that the development of intraoperative and postoperative complications in patients who will undergo liver surgery, in whom tissue blood flow is monitored with the help of devices, will be less than in patients who are followed up with traditional methods.
If an individual participate in this study, he will not be subjected to any additional procedures other than routine practice during the participant's operation. Before standard general anesthesia for his surgery, heart rate, oxygenation status, blood pressure parameters will be monitored. After the initiation of general anesthesia, the procedures performed in each liver surgery will be applied. In addition, he will be followed by using a probe that allows monitoring of tissue blood flow and reflects a value to the screen, to which it is attached, by simply sticking to his skin.
详细描述
Intraoperative tissue ischemia correlates with morbidity and mortality in critically ill patients. Therefore, measurement of tissue oxygenation is important in improving postoperative survival. Although values such as pulse oximetry, blood gas analysis, mixed venous oxygen saturation are routinely used to measure systemic oxygenation, regional tissue oxygen saturation measurement has not yet taken place in clinical practice.
The noninvasive measurement of human tissue oxygenation was first performed in 1874 by Karl Von Vierordt, with the detection of the reduction in the amount of infrared radiation passing through an ischemia-affected hand. The first portable oximeter was developed by Glen Milliken in 1942, but the device has only been used as an experimental tool in the aeronautical and physiology laboratory.
Adequate oxygen delivery (QO2) to meet the metabolic needs (VO2) of a tissue undergoing aerobic metabolism is critical for the long-term viability of this tissue. This condition was first described by Adolph Fick. For example, as the metabolic rate increases in peripheral tissues such as skeletal muscle, oxygen delivery will increase, so the amount of oxygen in the venous capillaries decreases and the arteriovenous oxygen difference increases. In addition, according to Fick's law, it is predicted that tissue oxygen delivery will increase with increasing oxygen gradient in microvascular tissue. Various invasive and/or expensive techniques have been developed to understand the balance between oxygen supply and consumption in peripheral tissue according to Fick's law. MR, PET, and arterial/venous catheterization are examples of these.
NIRS (Near Infrared Spectroscopy) Technology NIRS was first used in clinical practice in 1985 to measure cerebral oxygenation in preterm infants. It was developed to measure regional and systemic oxygenation noninvasively and continuously.
Its working principle is based on the measurement by attenuation of light of a certain wavelength (700-1000 nm) by chromophores such as hemoglobin in the sampled tissue by absorbing it in the tissue. The NIRS signal is mainly derived from hemoglobin in the entire vascular space, primarily small vessels (arterioles, capillaries, and venules). As a result, it provides the measurement of tissue hemoglobin or saturation (StO2) by measuring oxy and deoxy hemoglobin in the tissue. NIRS can also assist in estimating the amount of tissue hemoglobin by reflecting either the total tissue hemoglobin (HbT) or the absolute tissue hemoglobin index (THI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with ASA I-III physical status
- •patients between the ages of 18-75
- •patients who will undergo liver resection
排除标准
- •patients with ASA physical status of IV
- •patients with clinically significant cardiovascular, respiratory, renal or metabolic disease, ischemic cerebrovascular disease
- •Patients who have BMI >30
- •Patients who aged >75 years
- •Patients with intellectual disability
- •Patients who will have intraoperative surgical complications
- •Patients who will need for postoperative ventilation
- •Patients who have methemoglobinemia after intravascular dye injection
结局指标
主要结局
Hepatic and renal tissue oxygenation
时间窗: STO2 and O3 measurements at 24th hour postoperatively
we will evaluate the effects of hepatic and renal StO2 measurement on early hypoperfusion and postoperative survival in hepatectomy cases, and peripheral tissue oxygen saturation measurement with StO2 InSpectra Tissue Spectrometer Model 1615 probe (Hutchinson Technology Inc. Hutchinson, MN, USA) and O3TM Regional Oximeter System ( We aimed to observe by doing it with O3 System, Masimo Corporation, Irvine, CA) devices.
次要结局
- Vascular clamp duration(İntraoperative duration of vascular clamp (minute))
- ASA status(at 24th hour postoperatively)
- age(at 24th hour postoperatively)
研究者
Gul Cakmak
Principal investigator
Marmara University