Laser Speckle Contrast Analysis to Evaluate the Influence of the Consumption of Conventional and Electric Cigarettes on Skin Circulation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 198
- 试验地点
- 2
- 主要终点
- Perfusion of the extremities for non-smokers, smokers and vapers
研究概览
简要总结
The survey participants are divided into a smoking and non-smoking group. The smoker group is further divided according to the quantity and quality of nicotine ("normal" smoking, vaping). After reaching a steady state, the cutaneous blood flow at rest in the extremities of all participants is determined by Laser Doppler Imaging as a reference value. Laser Doppler Imaging produces images of the blood flow using perfusion units (PU). Subsequently, the perfusion is measured again after smoking/vaping. The difference in skin perfusion of the extremities is calculated (δ-Perfusion). All measurements are performed under controlled vital parameters (body temperature, systolic and diastolic blood pressure, heart rate) and controlled room temperature as well as 15-minute acclimatization of the patients.
详细描述
After consenting to the study, the subjects are examined using Laser Doppler Camera.
The skin blood flow of the extremities is determined as a reference value. Laser Doppler Imaging produces images of the blood flow using the perfusion units (PU).
All measurements are taken under controlled vital parameters (body temperature, systolic and diastolic blood pressure, heart rate) and controlled room temperature as well as 15-minute acclimatization of the subjects.
For smokers or vapers, the perfusion is measured again after consuming a cigarette or an e-cigarette respectively. The difference of blood flow after smoking or vaping is calculated using both measures.
The total duration of the study per subject is approximately 25-30 minutes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Double blind through randomization
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult non-smokers, smokers, vapers
排除标准
- •Adults with cardiopulmonary diseases
- •Pregnant women
- •Adults that participating in other surveys
结局指标
主要结局
Perfusion of the extremities for non-smokers, smokers and vapers
时间窗: 30 seconds
The perfusion of the extremities will be measured in Perfusion Units. The Perfusion Units are calculated directly through the Laser Doppler Camera as a result of the examination.
Difference of perfusion after smoking/vaping
时间窗: 30 seconds
The perfusion of the extremities will be measured after the consume of cigarettes/electronic cigarettes in Perfusion Units. The difference between the results of the examination before and after the consume of cigarettes/electronic cigarettes will be measured in Perfusion Units.
次要结局
- Correlation of perfusion with quantity of smoking/vaping(30 seconds)
- Correlation of perfusion with age(30 seconds)
- Correlation of perfusion with gender(30 seconds)
研究者
Andreas Kyriakou
Vacular Surgery Resident
University Hospital Muenster