A Comparison of the Party Balloon Assisted Valsalva With Conventional Valsalva Maneuver in Diagnosis of Superficial Venous Valvular Reflux of Lower Limb
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Number of successfully identified reflux with different method of Valsava technic
研究概览
简要总结
This study was designed to compare the party balloon assisted Valsalva with the conventional Valsava for exhibiting the reverse venous flow in superficial venous valvular incompetence duplex examination.
详细描述
In this study, we compared the Party Balloon assisted Valsalva with Conventional Valsalva maneuver in diagnosis of superficial venous valvular reflux of lower limb by crossover study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- 是
入选标准
- •Age within 18-80 years old
- •Visible GSV varicose veins
- •Trendelenburg test part 1 - Negative (Perforator vein incompetence) and
- •Trendelenburg test part 2 - Positive (Saphenofemoral junction competence)
- •Consent to participate in the study.
排除标准
- •- CVI from Klippel-Trenaunay syndrome, Deep vein thrombosis (DVT), Arteriovenous fistula (AVF)
- •Failure to language communication
- •Previous heart disease (CAD, Myocardial infarction, Stable angina, Unstable angina, Congestive Heart Failure, Valvular heart disease)
- •Previous lung disease (Asthma, Chronic obstructive pulmonary disease, Bronchiectasia)
- •Abnormalities of oral cavity which cannot hold own breath. (Cleft lip, Cleft palate)
结局指标
主要结局
Number of successfully identified reflux with different method of Valsava technic
时间窗: 20 minutes
Patients performed conventional Valsava for identify venous reflux on duplex scan for 3 times then they performed balloon assisted Valsava for identify venous reflux on duplex scan for 3 times. The Outcome is number of successfully identified reflux with different method of Valsava technic.
次要结局
- The timing of identified venous reflux demonstrated in the duplex scan of conventional Valsava and balloon assisted Valsava(20 minutes)
- The total timing for duplex scan examination in conventional Valsava and balloon assisted Valsava(20 minutes)
- The timing for the instruction of conventional Valsava and balloon assisted Valsava(20 minutes)