Influence of the Consumption of Conventional and Electric Cigarettes on Skin Circulation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Laser Speckle Contrast Analysis to Evaluate the Influence of the Consumption of Conventional and Electric Cigarettes on Skin Circulation

Conditions
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Nicotine Dependence, Vaping, Smoking

Intervention / Treatment
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* Behavioral: Use of nicotine product (smoking/vaping)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adult non-smokers, smokers, vapers Exclusion Criteria: Adults with cardiopulmonary diseases Pregnant women Adults that participating in other surveys

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two groups : consumers of cigarettes/e-cigarettes and non consumers of cigarettes/e-cigarettes
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No smokers<br>Healthy subjects who do not consume any nicotine products | |
| Experimental: Smokers/Vapers<br>Healthy subjects who consume nicotine products | Behavioral: Use of nicotine product (smoking/vaping)<br>* The smokers/vapers are consuming during the study one nicotine product of their own. The dose is the same as each individual is consuming regularly<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perfusion of the extremities for non-smokers, smokers and vapers | 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. | 30 seconds | 
| Difference of perfusion after smoking/vaping | 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. | 30 seconds | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of perfusion with age | The age (years) will be controlled as a possible factor that influence the perfusion. Therefore the results in Perfusion Units measured through Laser Doppler Camera will be statistically analyzed taking into consideration the age in years of each subject. | 30 seconds | 
| Correlation of perfusion with gender | The gender(male or female) will be controlled as a possible factor that influence the perfusion. Therefore the results in Perfusion Units measured through Laser Doppler Camera will be statistically analyzed taking into consideration the gender of each subject. | 30 seconds | 
| Correlation of perfusion with quantity of smoking/vaping | The quantity of smoking/vaping (packet years/nicotine quantity for vaping) will be controlled as apossible factor that influence the perfusion. Therefore the results in Perfusion Units measured through Laser Doppler Camera will be statistically analyzed taking into consideration the quantity of smoking of each related subject. | 30 seconds | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking, Perfusion, Laser Speckle Contrast Analysis, Laser Doppler Camera, Nicotine, Vaping