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临床试验/NCT04728178
NCT04728178已完成不适用

Comparison of Perioperative Standard Fluid Management and Goal-Directed Fluid Management in Patients Undergoing Head and Neck Surgery: A Prospective Randomized Clinical Trial

Istanbul University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Intraoperative fluid balance

研究概览

简要总结

To compare the goal-directed fluid therapy based on the data obtained from the hemodynamic monitoring system, which provides continuous CO, SV and SVV measurements through arterial pressure wave with standard fluid therapy in perioperative fluid management of patients undergoing head and neck surgery.

详细描述

Following the ethics committee approval and patients consent, the study was completed with a total of ASA I-III, 60 patients over the age of 18 who will undergo head and neck surgery.After randomization, patients underwent arterial cannulation. The arterial cannulas of the study group patients were integrated into the hemodynamic monitoring system with a special transducer, and their fluid management was planned to achieve a target value of 13% or less through SVV monitoring. In the control group, fluid management was set as MAP (Mean arterial pressure) 65 mmHg and above and diuresis 0.5ml/kg/hour and above. Crystalloid infusion at 7ml/kg/hour was started in both groups. When SVV value increased to 13% and over in the study group, 250 ml of crystalloid was given in the first stage, and if it continued to be 13% and over, 250 ml of colloid bolus was given. Vasoconstrictor agent was used when SVV was below 13% and MAP was below 65 mmHg. The patients in the control group were given 250 ml of crystalloid in the first stage if the MAP was below 65 mmHg, and 250 ml of colloid bolus if the hypotensive episode continued. If hypotension persisted despite these fluid boluses, a vasoconstrictor agent was used. In addition, when the diuresis of the patients was detected at 0.5mg/kg/hr or less, 250 ml of colloid bolus was administered.

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
None

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

入选标准

  • Volunteering to participate in the study
  • ASA classification 1, 2 or 3
  • The patients who will undergo head and neck surgery

排除标准

  • Being under the age of 18 or over the age of 80
  • Presence of serious cardiac, renal and liver pathology ( ejection fraction< %35 and/or glomerular filtration rate< 30ml/kg/min, kreatinin>2,5mg/dl and/or abnormal liver function test)
  • The patients who have heart rhythm problems such as atrial fibrillation, sinus tachycardia, ventricular extrasystoles
  • The patients who have a peripheral arterial disease
  • Being a morbid obese ( BMI>40 kg/m2)
  • the patients who may have considered difficult airway

结局指标

主要结局

Intraoperative fluid balance

时间窗: during surgery

the total and additional amount of crystalloid and colloid fluid fluid given during the surgery

次要结局

  • Prolonged IMV demand(during 8 hours after surgery)
  • Prolonged oxygen demand(during 8 hours after surgery)
  • Heart rate(during surgery)
  • hypoxia(during surgery)
  • hypercarbia(during surgery)
  • pulmonary infection(postoperative period (up to 6 weeks))
  • Blood Pressure(during surgery)
  • hospitalisation time(postoperative period (up to 6 weeks))
  • lenght of stay in ICU(postoperative period (up to 6 weeks))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Demet Altun

attending anesthesiologist

Istanbul University

研究点 (2)

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