Effects of Remote Ischemic Preconditioning During Free Flap Reconstruction in Head and Neck Cancer Patients: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- tissue oxygen saturation
研究概览
简要总结
Remote ischemic preconditioning (RIPC) has been revealed organ-protective effect in many previous clinical settings including coronary intervention or cardiovascular surgery. However its protective role during free flap reconstructive surgery in head and neck cancer patients has not yet been elucidated. The purpose of the current study is to evaluate the effect of RIPC on tissue oxygen saturation and skin temperature of the flap, as well as its organ-protective effect using Langendorff isolated heart ischemia-reperfusion model.
详细描述
Patients undergoing free flap reconstructive surgery for head and neck cancer will be randomized to either remote ischemic preconditioning (RIPC) group or control group. On the day of surgery, after induction of anesthesia, RIPC, consisting of 4 cycles of 5-min ischemia (using pneumatic cuff pressure of 200 mmHg) followed by 5-min reperfusion at upper arm, or sham-RIPC (pressure < 10 mmHg) will be induced in the RIPC or control group, respectively. Before completion of surgery, RIPC or sham-RIPC will be repeated. Tissue oxygen saturation and skin temperature of the flap will be recorded until postoperative day 1.
As a sub-study, blood samples will be obtained before and after RIPC/sham-RIPC. From them, plasma dialysate will be prepared to use for Langendorff isolated heart model. Myocardial infarct size of Langendorff rat heart will be compared between the groups to evaluate organ protective effect of RIPC during free flap reconstuctive 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing free flap reconstructive surgery
排除标准
- •BMI < 18, > 35 kg/m^2
- •AV fistula at arm, any reason to protect arm
- •vascular abnormality or discomfort at arm
- •peripheral vascular disease, peripheral neuropathy, or coagulopathy
- •uncontrolled diabetes mellitus
- •preoperative use of beta-blocker
- •history of radiation therapy
- •refuse to enrol
研究组 & 干预措施
Remote ischemic preconditioning (RIPC)
Intervention is remote ischemic preconditioning (RIPC) consists of 4 cycles of 5-min ischemia (using pneumatic cuff pressure of 200 mmHg) and subsequent 5-min reperfusion applied to upper arm.
干预措施: remote ischemic preconditioning (RIPC) (Procedure)
Control (Sham-RIPC)
Intervention is Sham-RIPC (ischemia pressure < 10 mmHg) applied to upper arm.
干预措施: sham-RIPC (Procedure)
结局指标
主要结局
tissue oxygen saturation
时间窗: postoperative day 1
tissue oxygen saturation of free flap
次要结局
未报告次要终点
研究者
Youn Joung Cho, MD
Clinical assistant professor
Seoul National University Hospital