Effects of Remote Ischemic Preconditioning During Free Flap Reconstruction in Head and Neck Cancer Patients With Preoperative Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- tissue oxygen saturation
研究概览
简要总结
Remote ischemic preconditioning (RIPC) has shown organ-protective effects in many clinical settings including patients with ischemic heart disease. However its protective role in head and neck cancer patients with preoperative radiotherapy undergoing free flap reconstructive surgery has not yet been evaluated. The purpose of the current study is to evaluate the effect of RIPC on tissue oxygen saturation and skin temperature of the flap.
详细描述
Patients undergoing free flap reconstructive surgery for head and neck cancer with preoperative radiotherapy 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 the 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.
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
- •Adult head and neck cancer patients undergoing free flap reconstructive surgery with preoperative radiotherapy
排除标准
- •Radiotherapy within 4 weeks
- •Body mass index < 18 kg/m^2 or > 35 kg/m^2
- •Presence of AV fistula at the arm, any reason to protect arms
- •Presence of vascular abnormality or discomfort at arms
- •Peripheral vascular disease, peripheral neuropathy, or coagulopathy
- •Uncontrolled diabetes mellitus
- •Preoperative use of beta-blockers
- •Refuse to enrol
研究组 & 干预措施
RIPC
Remote ischemic preconditioning (RIPC) consisted of 4 cycles of 5-min ischemia using pneumatic cuff pressure of 200 mmHg and 5-min reperfusion is applied to the upper arm of the patients in the RIPC group.
干预措施: remote ischemic preconditioning (RIPC) (Other)
Sham-RIPC
Sham-RIPC consisted of 4 cycles of 5-min ischemia using pneumatic cuff pressure of < 10 mmHg and 5-min reperfusion is applied to the upper arm of the patients in the Sham-RIPC group.
干预措施: Sham-RIPC (Other)
结局指标
主要结局
tissue oxygen saturation
时间窗: postoperative day 1
tissue oxygen saturation of the flap
次要结局
- skin temperature(postoperative day 1)
研究者
Youn Joung Cho, MD, PhD
Clinical assistant professor
Seoul National University Hospital