Influence of the Consumption of Conventional and Electric Cigarettes on Skin Circulation
- Conditions
- VapingNicotine DependenceSmoking
- Interventions
- Behavioral: Use of nicotine product (smoking/vaping)
- Registration Number
- NCT04645914
- Lead Sponsor
- University Hospital Muenster
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 198
Healthy adult non-smokers, smokers, vapers
- Adults with cardiopulmonary diseases
- Pregnant women
- Adults that participating in other surveys
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Smokers/Vapers Use of nicotine product (smoking/vaping) Healthy subjects who consume nicotine products
- Primary Outcome Measures
Name Time Method Perfusion of the extremities for non-smokers, smokers and vapers 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 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.
- Secondary Outcome Measures
Name Time Method Correlation of perfusion with quantity of smoking/vaping 30 seconds 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.
Correlation of perfusion with age 30 seconds 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.
Correlation of perfusion with gender 30 seconds 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.
Trial Locations
- Locations (1)
University Hospital Muenster
🇩🇪Muenster, Nordrhein-Westfalen, Germany