Clinical Trial for Evaluation of Arterial and Plethysmographic Waveform Variations as Predictors of Hemodynamic Response to Pneumoperitoneum During Laparoscopic Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Cardiac output/cardiac index
研究概览
简要总结
Laparoscopic surgery is frequently associated with hemodynamic changes due to pneumoperitoneum (PnP). Those complex hemodynamic changes are difficult to predict and occasionally they require active therapeutic interventions or even interruption of the surgical procedure.
One of the main hemodynamic effects of PnP is a decrease in cardiac output due to reduction of venous return and cardiac preload. Although it has been shown repeatedly that waveform variables are good predictors of cardiac output response to volume loading, the prediction hemodynamic response to decrease of preload is more complex.
The investigators hypothesize that waveform variables will predict cardiac output changes resulting from PnP. Particularly, augmented values of waveform variables before PnP will be associated with a larger decrease of cardiac output after establishing PnP.
详细描述
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Goals of the study
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To evaluate hemodynamic changes caused by pneumoperitoneum applied for laparoscopic surgery
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Endpoints
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Blood Pressure: Systolic, Diastolic, Mean (SBP, DBP, MBP)
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Heart Rate (HR)
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Cardiac Output/Index (CO/CI)
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Stroke Volume/Index (SV/SVI)
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Systolic Pressure Variation (SPV)
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Stroke Volume Variation (SVV)
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Plethysmographic Waveform Variation (PWV)
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Inclusion criteria
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The patients scheduled for elective laparoscopic partial hepatectomy, laparoscopic splenectomy, laparoscopic pancreatectomy - required of continuous direct blood pressure monitoring according to the type of surgery
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The patients ASA (American Society of Anesthesiologists)class III-IV scheduled for elective laparoscopic colectomy and hemicolectomy - required of continuous direct blood pressure monitoring according to their medical condition
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Pneumoperitoneum by needle application only
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Normal sinus cardiac rhythm
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Exclusion criteria
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Patients that didn't sign informed consent
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Patients ASA class I-II scheduled for elective laparoscopic colectomy or hemicolectomy
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Patients scheduled for elective laparoscopic cholecystectomy
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Patients required of monitoring by pulmonary artery catheter during the surgery according to their medical condition
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Study course, measurements and analysis
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients scheduled for elective laparoscopic partial hepatectomy, laparoscopic splenectomy, laparoscopic pancreatectomy - required of continuous direct blood pressure monitoring according to the type of surgery
- •The patients ASA class III-IV scheduled for elective laparoscopic colectomy and hemicolectomy - required of continuous direct blood pressure monitoring according to their medical condition
- •Pneumoperitoneum by needle application only
- •Normal sinus cardiac rhythm
排除标准
- •Patients that didn't sign informed consent
- •Patients ASA class I-II scheduled for elective laparoscopic colectomy or hemicolectomy
- •Patients scheduled for elective laparoscopic cholecystectomy
- •Patients required of monitoring by pulmonary artery catheter during the surgery according to their medical condition
结局指标
主要结局
Cardiac output/cardiac index
时间窗: Change of intraabdominal pressure before and 2-5 min after pneumoperitoneum
Cardiac output/cardiac index will be measured before applying of pneumoperitoneum, 2-5 min after applying of pneumoperitoneum with intraabdominal pressure of 15 mmHg and 2-5 min after decrease of intraabdominal pressure until 10 mmHg
次要结局
- Systolic pressure variation (SPV)/Pulse pressure variation (PPV)(Change of intraabdominal pressure before and 2-5 min after pneumoperitoneum)