Comparison of Fluid Administered According to Plethysmographic Variability Index Versus Ideal Fluid Management in Laparoscopic Trendelenburg Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- PVI (pleth variability index)
研究概览
简要总结
Investigating the ideal fluid management in Trendelenburg positions during lower abdominal laparoscopic surgeries in gynecological oncology and surgical oncology patients
详细描述
Laparoscopic lower abdominal surgeries include carbon dioxide (CO2) insufflation and an advanced Trendelenburg position with the head down. Increased intra-abdominal pressure can reduce cardiac index and cause changes in total body fluid balance. However, the head down Trendelenburg position increases intracranial pressure and preload. According to traditional fluid management, intraoperative fluid deficit is calculated according to the 4-2-1 rule, by summing up hourly basal fasting level, intraoperative losses due to degree of tissue trauma (1-2mlt/kg/h in minor surgeries, 2-4mlt/kg/h in medium surgeries, 4-8mlt/kg/h in major surgeries), blood losses, urine and losses from nasogastric tube.
Preservation of intravascular volume and thus provision of hemodynamic stability are among the factors affecting postoperative morbidity and mortality. Some studies have shown that standard fluid therapy is more than necessary. Current guidelines recommend more restrictive approaches by ensuring hemodynamic stability. Masimo, which we also use routinely in our clinic, is a device designed for continuous noninvasive monitoring of arterial hemoglobin functional oxygen saturation (SpO2), pulse rate (PR), pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index) values. In our study, in the individualization of the recommended target-oriented restrictive fluid therapy in major surgeries, by comparing the calculated fluid amount with traditional fluid management with PVI values (PVI is evaluated between 0-100.
Normavolemia 15-25 low fluid responsiveness <15 high fluid responsiveness >25) and when the patient's massimo pvi score is >25, 300cc bolus fluid will be administered and fluid will be loaded at an average speed and the PVI value will be reduced below 25. When the patient's massimo PVI value is below 25, restrictive fluid therapy will be followed.(A crystalloid fluid infusion of 2 mL/kg was administered to the patients.)
The aim was to investigate the ideal fluid management in Trendelenburg positions in lower abdominal laparoscopic surgeries performed in gynecological oncology and surgical oncology patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •between the ages of 18-80
- •patients with ASA score II III
- •Laparoscopic lower abdominal surgery (patients undergoing gynecological oncology and surgical oncology surgery)
排除标准
- •xclusion Criteria:
- •ASA score IV
- •Patients with heart failure and chronic kidney disease
- •Patients who did not agree to participate in the study
- •Cases that started laparoscopically and converted to laparotomy
研究组 & 干预措施
Massimo group
The patient is not given fluids until the Massimo PVI score is >25, a 300 cc fluid bolus is given when the PVI is above 25, and fluid loading is performed at an average rate until the PVI falls below 25. If the patient's Massimo PVI is below 25, restrictive fluid therapy is applied.
干预措施: massimo group (Device)
standart group
intraoperative fluid deficit is calculated according to the 4-2-1 rule by summing up the hourly basal fasting level, intraoperative losses depending on the degree of tissue trauma (1-2mlt/kg/h in small-sized surgeries, 2-4mlt/kg/h in medium-sized surgeries, 4-8mlt/kg/h in large-sized surgeries), blood losses, urine and losses from the nasogastric tube. Fluid is given in this way.
干预措施: standart group (Other)
结局指标
主要结局
PVI (pleth variability index)
时间窗: five minute send of surgery
arterial hemoglobin functional oxygen saturation % (SpO2), pulse rate BPM (PR), pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index) values
SPO2 (hemoglobin functional oxygen saturation)
时间窗: five minute send of surgery
arterial hemoglobin functional oxygen saturation % (SpO2), pulse rate BPM (PR), pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index) values
PI (perfusion index)
时间窗: five minute send of surgery
arterial hemoglobin functional oxygen saturation % (SpO2), pulse rate BPM (PR), pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index) values
PR (pulse rate beats per minute)
时间窗: five minute send of surgery
arterial hemoglobin functional oxygen saturation % (SpO2), pulse rate BPM (PR), pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index) values
PI (perfusion index)
时间窗: ten minutes results before induction
arterial hemoglobin functional oxygen saturation % (SpO2), pulse rate (PR) beats per minute, pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index) values
PVI (pleth variability index)
时间窗: ten minutes results before induction
arterial hemoglobin functional oxygen saturation % (SpO2, pulse rate (PR) beats per minute, pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index) values
SPO2 (hemoglobin functional oxygen saturation)
时间窗: ten minutes results before induction
arterial hemoglobin functional oxygen saturation % (SpO2), pulse rate (PR) beats per minute, pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index) values
PR (pulse rate beats per minute)
时间窗: ten minutes results before induction
arterial hemoglobin functional oxygen saturation % (SpO2), pulse rate (PR) beats per minute, pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index) values
PI (perfusion index)
时间窗: ten minutes when c02 insufflation is performed into the abdomen
arterial hemoglobin functional oxygen saturation (SpO2), pulse rate BPM (PR), pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index) values
PVI (pleth variability index)
时间窗: ten minutes when c02 insufflation is performed into the abdomen
arterial hemoglobin functional oxygen saturation (SpO2), pulse rate BPM (PR), pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index) values
SPO2 (hemoglobin functional oxygen saturation)
时间窗: ten minutes when c02 insufflation is performed into the abdomen
arterial hemoglobin functional oxygen saturation (SpO2), pulse rate BPM (PR), pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index) values
PR (pulse rate beats per minute)
时间窗: t2(ten minutes when c02 insufflation is performed into the abdomen
arterial hemoglobin functional oxygen saturation (SpO2), pulse rate BPM (PR), pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index) values
PI (perfusion index)
时间窗: two hours during the surgery in the trendelenburg position
arterialhemoglobin functional oxygen saturation % (SpO2), pulse rate BPM (PR), pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index) values
PVI (pleth variability index)
时间窗: two hours during the surgery in the trendelenburg position
arterialhemoglobin functional oxygen saturation % (SpO2), pulse rate BPM (PR), pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index) values
SPO2 (hemoglobin functional oxygen saturation)
时间窗: two hours during the surgery in the trendelenburg position
arterialhemoglobin functional oxygen saturation % (SpO2), pulse rate BPM (PR), pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index) values
PR (pulse rate beats per minute)
时间窗: two hours during the surgery in the trendelenburg position
arterialhemoglobin functional oxygen saturation % (SpO2), pulse rate BPM (PR), pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index) values
次要结局
未报告次要终点
研究者
Ela Erdem Hıdiroglu
principal investigator
Ankara Etlik City Hospital