NCT03286231已完成不适用
Anti-FLEX: Flexed Levering of Gluteal Vessels on OR Table May Lead to Extreme Danger During Gluteal Augmentation With Lipoaspirate, a Radio-graphically Studied Position of Superior and Inferior Gluteal Vessels During Flexion of OR Table or "Jack-knife" Position, Danger Zone.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Mean difference of position of the gluteal venous vasculature in relation to the skin
研究概览
简要总结
The purpose of this study is to evaluate the effect of the gluteal vasculature in the prone and jackknife positions.
详细描述
This is a prospective collection of contrast-enhanced CT images of healthy female volunteers in prone and jackknife positions in order to determine if position impacts gluteal venous vasculature.
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
- 20 Years 至 50 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females age 20 - 50 years
- •BMI between 20 - 35 kg/m2
- •Willingness and ability to provide written informed consent
- •Willingness and ability to comply with all study procedures
- •Interested or planning to have a gluteal augmentation
排除标准
- •Females age < 20 or >= 51 years
- •BMI between < 20 or > 35 kg/m2
- •Prior gluteal augmentation surgery
- •Any prior gluteal soft tissue filler
- •Known or suspected history of immediate or delayed hypersensitivity (including but not limited to hives, anaphylactoid or cardiovascular reactions, laryngeal edema, and bronchospasm) to iodine or any iodinated contrast medium
- •Documented history of chronic kidney disease that contraindicates the use of contrast dye
- •Currently breast-feeding
- •Any reason (in addition to those listed above) that, in the opinion of the principal investigator, precludes full participation in the study
结局指标
主要结局
Mean difference of position of the gluteal venous vasculature in relation to the skin
时间窗: at CT scan visit
Between the Prone position and the Jackknife position
次要结局
- Mean difference of vessel diameter of the gluteal venous vasculature(at CT scan visit)
- Mean difference of the danger zone(at CT scan visit)
研究者
研究点 (1)
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