Bioimpedance Measurement of Abdominal Free Flaps During Arterial and Venous Weaning in Breast Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Measurement of impedence
研究概览
简要总结
As the occurrence of thrombosis in post surgery is rare, it seemed difficult to study only this one. This is why we decided to test the bioimpedance, temperature and green, red and infrared light absorption measurements of the prototype during the weaning of the flap during surgery. Indeed, during weaning the investigators voluntarily interrupt the arterial and venous flow to transfer the flap to the breast. This weaning corresponds to a thrombosis model.
The patients will benefit from an "improved" postoperative monitoring. Indeed, in addition to the classical clinical monitoring, they will benefit from an additional monitoring during 5 days thanks to the realization of an ultrasound of the flap which will be carried out every 6 hours the first 24 hours then every 12 hours.
This protocol is therefore a feasibility study for the collection of data of interest.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Woman undergoing microsurgical breast reconstruction using a free abdominal flap
- •Age greater than or equal to 18 years
排除标准
- •Pregnant patient
- •Patient with an active implantable device such as a pacemaker or an artificial heart
- •Patient refusing to participate in the study
- •Age less than 18 years old
结局指标
主要结局
Measurement of impedence
时间窗: one day
Impedence measurement during episode of ischemia.
次要结局
未报告次要终点
