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临床试验/NCT04775576
NCT04775576已完成不适用

Comparison of Conventional Fluid Management Protocol With Targeted Pleth Variability Index (PVI) Monitoring Protocol During Total Abdominal Hysterectomy and Bilateral Salpingooferectomy Operation

Dr. Lutfi Kirdar Kartal Training and Research Hospital2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2021年2月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
78
试验地点
2
主要终点
compare the control group (conventional fluid management) with the PVI group (Pleth Variability Index and SpHb guided targeted fluid management) protocol.

研究概览

简要总结

This study aims to compare the volume management methods performed by using conventional method and PVI monitoring in intraoperative fluid treatment during bilateral salpingo-oophorectomy and total hysterectomy operation.

详细描述

Intraoperative fluid management is very important in terms of postoperative organ perfusion and complications. While various complications such as acute renal failure, hypotension, arrhythmia, anastomotic leakage can be seen due to intraoperative hypovolemia; Hypervolemia can cause pulmonary edema, postoperative pneumonia, prolonged mechanical ventilation need, delayed wound healing, gastrointestinal system (GIS) edema and decreased intestinal motility.

Increasing the quality of intraoperative fluid therapy is a situation that may affect the morbidity and mortality of patients due to all these reasons.

Conventional fluid management is widely used in clinical practice. In this method, the fluid need of the patient is decided according to pulse, arterial blood pressure, central venous pressure, urine output and clinical condition. In the targeted fluid therapy method, besides static parameters such as pulse, arterial blood pressure, central venous pressure; Dynamic parameters such as Stroke volume variability (SVV), pulse pressure variability (PPV), pleth variability index (PVI), continuous hemoglobin (SpHb) are also used noninvasively. Studies related to SpHb, which provides noninvasive continuous hemoglobin monitoring in accordance with pulse oximetry, show that there is a decrease in blood product transfusion compared to cases managed with conventional laboratory follow-up.

Our primary goal is to compare the control group (conventional fluid management) with the PVI group (Pleth Variability Index and SpHb guided targeted fluid management) protocol.

For this purpose, we aim to compare the amount of crystalloids and blood products, blood lactate, serum creatinine and electrolyte levels applied in the intraoperative period as a result of both protocols. Our secondary aim will be to compare the length of stay in the hospital.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Total abdominal hysterectomy and bilateral salpingooferectomy operation is planned Patients in the ASA 1-2-3 group

排除标准

  • Under 18 years old Severe cardiac arrhythmia Ejection fraction ≤ 30% Acute and / or chronic renal failure Patients who need more than 8ml / kg tidal volume due to advanced stage COPD

结局指标

主要结局

compare the control group (conventional fluid management) with the PVI group (Pleth Variability Index and SpHb guided targeted fluid management) protocol.

时间窗: 0-180 minute

compare the amount of crystalloids,colloids and blood products, blood lactate, serum creatinine and electrolyte levels applied in the intraoperative period as a result of both protocols.

次要结局

  • Postoperative length of stay in hospital(24 hours)
  • Postoperative Lung complications(24 hours)
  • Postoperative kidney injury(24 hours)

研究者

发起方
Dr. Lutfi Kirdar Kartal Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Ummahan Dalkilinc Hokenek

Anesthesiology and Reanimation Specialist

Dr. Lutfi Kirdar Kartal Training and Research Hospital

研究点 (2)

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