跳至主要内容
临床试验/NCT03064880
NCT03064880Unknown不适用

Does Preoperative Maximization Fluid Strategies for Goal-directed Therapy Affect Physiological Changes Following One-lung Ventilation

National Taiwan University Hospital0 个研究点目标入组 60 人开始时间: 2017年3月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
主要终点
intraoperative physiological changes and managements

研究概览

简要总结

Intraoperative goal-directed fluid therapy (GDFT) is proposed to improve the outcomes of patients undergoing major surgery. In the GDFT algorithm, the employment of fluid bolus plays a crucial role. Dynamic fluid responsiveness parameters, such as stroke volume (SV) response to fluid infusion, are precise fluid indicators that specifically determine patient volume status and are helpful for clinicians to determine the appropriate time for fluid bolus. In this study, we compared two fluid strategies guided by SV response, namely maximization and nonmaximization protocols, during intraoperative GDFT for patients undergoing thoracic surgery requiring one-lung ventilation. Clinical outcomes and perioperative changes in serum biomarkers of oxidative injury were compared between the two groups as the primary and secondary outcomes respectively.

详细描述

Intraoperative goal-directed fluid therapy (GDFT) is proposed to improve the outcomes of patients undergoing major surgery. In the GDFT algorithm, the employment of fluid bolus plays a crucial role. Dynamic fluid responsiveness parameters, such as stroke volume (SV) response and stroke volume variation (SVV), are precise fluid indicators that specifically determine patient volume status and are helpful for clinicians to determine the appropriate time for fluid bolus. During GDFT, fluid is commonly administered to maximize perfusion by maintaining patient blood volume at the plateau portion of the Frank-Starling curve by keeping patient at a lower SV response (i.e., SV increase < 10% and maintained for 20 minutes). However, maximization does not necessarily imply optimization; the role of fluid maximization of perfusion in GDFT remains controversial.Moreover, the importance of intraoperative GDFT in thoracic surgery has rarely been explored, because most intraoperative GDFTs have been conducted during abdominal surgery. Acute lung injury (ALI) following thoracic surgery remains a major source of morbidity and mortality after lung resection. Despite the advancement in both the surgical techniques and the perioperative management, the incidence of postoperative ALI remains remarkable. Risk factors are evident, including preoperative pulmonary function, type of surgical procedure, intraoperative fluid management, one-lung ventilation, and ventilator settings. Fluid management for thoracic surgery is challenging. Evidence has shown the association between excessive fluid administration and development of acute lung injury. Therefore, fluid restriction may benefit patients undergoing thoracic surgery. By contrast, restrictive fluid management incurs risks such as a hypovolemic state with impaired tissue perfusion which may result in organ dysfunction and in particular postoperative acute kidney injury. Accordingly, maintenance of perfusion through a maximized fluid protocol may be favorable. However, this debate has not yet been investigated.In this study, two fluid strategies guided by SV response, namely maximization and nonmaximization protocols, during intraoperative GDFT for patients undergoing thoracic surgery requiring one-lung ventilation. Clinical outcomes and perioperative changes in serum biomarkers of oxidative injury were compared between the two groups as the primary and secondary outcomes respectively.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Thoracic patients requiring thoracic surgery and lung isolation
  • Age 20 - 70 years old

排除标准

  • Arrhythmia and irregular heart beats
  • End-stage organ disease and difficult to manipulate fluid status
  • Pregnant women

结局指标

主要结局

intraoperative physiological changes and managements

时间窗: 1day

collected from anesthetic record including blood pressure changes(mmHg), data from arterial blood gas, use of vasoconstrictors, etc.,

Clinical outcomes (postoperative)

时间窗: 1 year

collected from chart review including feeding time(hrs postop), hospitalization (days) ICU stay(hrs), any cardiac, pulmonary, and other major organ complications up to 12 months

次要结局

  • Perioperative oxidative injury biomarkers(1 day)

研究者

申办方类型
Other
责任方
Sponsor

相似试验