Effect of Goal-Directed Fluid Therapy on the Postoperative Outcome in Head and Neck Cancer Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 340
- 试验地点
- 1
- 主要终点
- Serious complications occurred within 30 days after surgery
研究概览
简要总结
The goal of this clinical trial is to evaluate whether goal-directed fluid therapy (GDFT) can improve the postoperative recovery in patients undergoing head and neck cancer surgery. It aims to answer is:
• Whether GDFT can reduce the occurrence of serious postoperative complications? Researchers will compare GDFT protocol to a standard conventional fluid therapy in head and neck cancer surgery to see if GDFT strategy works to improve the postoperative recovery.
Participants will
- Receive GDFT protocol or a conventional fluid therapy during the surgery.
- Be continuously follow-up during hospitalization and after discharge to record the occurrence of postoperative complications.
详细描述
Postoperative complications have become the main cause of prolonged hospitalization and reduced postoperative survival rate among surgical patients. Goal-Directed Fluid Therapy (GDFT) has been reported to reduce the incidence of postoperative complications and mortality, shorten the hospital stay, and improve the outcome in major abdominal surgery patients. However, the benefit of the GDFT in patients undergoing head and neck surgery remains controversial. The purpose of this study is to evaluate whether GDFT can reduce the occurrence of serious postoperative complications and shorten the postoperative hospital stay, compared with a standard conventional fluid therapy in patients undergoing head and neck cancer surgery.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Patients were unaware of their group allocation. Due to the presence of the cardiac index trend monitoring device, care providers who supported to fluid strategy administration in the operating room could not be blinded. The outcomes assessor were blinded to the allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (Age≥18)
- •Scheduled to undergo head and neck cancer surgery (including nasopharyngeal carcinoma, laryngocarcinoma, hypopharyngeal carcinoma, and other head and neck malignancies, but not thyroid cancer) with an expected duration of 2 hours or longer
- •Agree to receive invasive artery blood pressure monitoring
排除标准
- •American Society of Anesthesiologists (ASA) classification>Ⅳ
- •Palliative surgery was performed for the terminal tumors
- •Microlaryngoscopic laser surgery or endoscopic surgery
- •Underwent major thoracic or abdominal surgery within 30 days
- •Regular renal replacement therapy is required
- •NYHA grade>3 or ejection fraction <30%
- •Lung disease does not tolerate the tidal volume by 8 ml/kg
- •Atrial fibrillation
- •Unable to give informed consent
- •pregnant or lactating woman
- •Emergency surgery
结局指标
主要结局
Serious complications occurred within 30 days after surgery
时间窗: within 30 days after surgery
Unit: %; All postoperative complications will be evaluated according the Clavien-Dino classification(CDc) of surgical complications. Each complication has an equal weight, and patients with at least one complication will be considered to have experienced postoperative complications. The serious postoperative complications were defined as CDc≥3.
次要结局
- All complications within 30 days after surgery(within 30 days after surgery)
- Cost of hospitalization(1 months after operation)
- The length of hospital stay after surgery(1 months after operation)
- Quality of Recovery Score(At 1,3, and 5 days after surgery)