Goal Directed Fluid Management and Patient Outcome in Free Flap Reconstructive Surgery for Head and Neck Oncology: a Feasibility Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- The volume of fluid administered intraoperatively during reconstructive surgery for head and neck oncology
研究概览
简要总结
Wide excision of head and neck cancer with microsurgical free flap's reconstruction (FFR) results to a high cancer cure rate and a good functional recovery. However, this long complex procedure is accompanied with considerable complications. Excessive fluid administration during this type of surgery has been connected with poor results. There is growing evidence that goal-directed fluid management (GDFM) might improve the results in high-risk patients.
Hypothesis: Goal directed fluid management will reduce intraoperative fluid volume administered to patients undergoing head and neck reconstructive surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
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
- 否
入选标准
- •Age 18-80 years
- •Signed informed consent
排除标准
- •History CHF
- •Severe valvular heart defects, intra cardiac shunts
- •Irregular heart rhythm
- •Allergy to hydroxyethyl starch solutions
- •Coagulation abnormalities (INR>1.5, aPTT>40s, platelet count<100x10 9/L
- •History of severe bleeding disorders
- •Renal insufficiency with creatinine >200Umol/L
- •Pregnant of nursing women
- •History of skin disorders that are accompanied by chronic puritis
结局指标
主要结局
The volume of fluid administered intraoperatively during reconstructive surgery for head and neck oncology
时间窗: Initiation of surgery to end of surgery on average 8-10 hours
次要结局
- Incidence of major complication and LOS(Post operative day 0 to hospital discharge)