The Application of Goal-directed Therapy With the Combination of Stroke Volume Variation and Cardiac Index as the Primary Judgment in Non-severe Patients Underwent Gastrointestinal Tumor Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 主要终点
- Number of Days Needed for Anal Exsufflation After Surgery
研究概览
简要总结
To evaluate the application of fluid-infusion therapy with the combination of stroke volume variation (SVV) and cardiac index (CI) as the primary judgment in non-severe patients underwent resection of gastrointestinal tumor. Fifty patients (ASA Ⅰ-Ⅱ, 26-55 years old, cardiac functional gradingⅠ) scheduled for gastrointestinal tumor surgery were divided into two groups randomly: group C with CI as the primary judgment and group S with the combination of SVV and CI as the primary judgment.
详细描述
To evaluate the application of fluid-infusion therapy with the combination of stroke volume variation (SVV) and cardiac index (CI) as the primary judgment in non-severe patients underwent resection of gastrointestinal tumor.
Methods: Fifty patients (ASA Ⅰ-Ⅱ, 18-55 years old, cardiac functional gradingⅠ) scheduled for gastrointestinal tumor surgery were divided into two groups randomly: group C with CI as the primary judgment and group S with the combination of SVV and CI as the primary judgment. Patients in group C received a therapy with the goal of CI was no less than 2.5L•min-1•m-2 while SVV was less than 12% and CI was no less than 2.5L•min-1•m-2 in group S. Indexes including MAP、HR、CVP、CI、SVV were recorded at the moment after anaesthetized (T1), when skin was incised (T2), when the intestina was anastomosed (T3) and after the abdomen was closed (T4). SaO2、ScvO2 and plasma lactic were determined at T1 and T4 and DO2,VO2 and ERO2 during the surgery were calculated .The volume of fluid, vasoactive drugs use, the incidence of adverse cardiovascular events, the convalescence of intestinal peristalsis, hospital stay and postoperative complications were recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) physical status of grade I-II
- •Cardiac function classification by NYHA of grade I
- •without high risk factors according to the revised Lee cardiac risk index:
- •High-risk type of surgery
- •Ischemic heart disease
- •History of congestive heart failure
- •History of cerebrovascular disease
- •Insulin therapy for diabetes
- •Preoperative serum creatinine > 2.0 mg/dl
- •undergoing gastrointestinal tumor surgery
排除标准
- •Patients under 18 years or above 55 years
- •patients with severe aortic regurgitation
- •patients with permanent cardiac arrhythmias
- •patients with intra-aortic balloon pump
- •patients with severe pulmonary disease
- •patients with hepatic or renal dysfunction
- •patients undergoing emergency surgery
结局指标
主要结局
Number of Days Needed for Anal Exsufflation After Surgery
时间窗: up to 8 weeks
record the number of days needed for anal exsufflation in non-severe patients after gastrointestinal tumor surgery
次要结局
- Oxygen Consumption（VO2）(during the surgery)
- Oxygen Extraction Rate（ERO2）(during the surgery)
- Number of Days in Hospital(up to 10 weeks)
- the Incidence of Adverse Cardiovascular Events(during the surgery)
- Oxygen Delivery（DO2）(during the surgery)
研究者
Lin Yang
Attending Physician
First Affiliated Hospital, Sun Yat-Sen University