跳至主要内容
临床试验/NCT02337920
NCT02337920已完成不适用

Prediction of Femoral Revascularization Quality Using the Somatic NIRS Signal

University Hospital, Caen1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2015年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
31
试验地点
1
主要终点
Relationship between the Maximum NIRS difference before and during the femoral artery clamping and the increase of walking perimeter

研究概览

简要总结

Despite effective femoral artery endarteriectomy, patients with occlusive arteritis may need complementary stenting of revascularization procedures within the 2 years after the primary surgery because of a poor blood supply in their lower limb extremity. The Near infrared spectrophotometry (NIRS) is a non-invasive monitoring of the brain or tissue oxygenation and provide information on the quality of the local oxygen supply. The aim of our observational study is to correlate the intraoperative NIRS variations at the calf and the soles and the one-year evolution of the arteritis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

入选标准

  • Patients undergoing unilateral femoral endarteriectomy

排除标准

  • emergency surgery, allergy to adhesive glues, skin abnormalities of the operated leg, multiple associated revascularization procedures other than endarteriectomy

结局指标

主要结局

Relationship between the Maximum NIRS difference before and during the femoral artery clamping and the increase of walking perimeter

时间窗: Change - One month, six months and one year after the surgery

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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