Clinical trial NCT04645914: Influence of the Consumption of Conventional and Electric Cigarettes on Skin Circulation
Official title: Laser Speckle Contrast Analysis to Evaluate the Influence of the Consumption of Conventional and Electric Cigarettes on Skin Circulation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nicotine Dependence
Vaping
Smoking
Keywords: Perfusion
Laser Speckle Contrast Analysis
Laser Doppler Camera
Nicotine
Smoking
Vaping
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
First posted: 2020-11-27
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups : consumers of cigarettes/e-cigarettes and non consumers of cigarettes/e-cigarettes
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: Inclusion Criteria:

Healthy adult non-smokers, smokers, vapers

Exclusion Criteria:

* Adults with cardiopulmonary diseases
* Pregnant women
* Adults that participating in other surveys

Primary outcomes:
measure: Perfusion of the extremities for non-smokers, smokers and vapers
timeFrame: 30 seconds
measure: Difference of perfusion after smoking/vaping
timeFrame: 30 seconds
Secondary outcomes:
measure: Correlation of perfusion with age
timeFrame: 30 seconds
measure: Correlation of perfusion with gender
timeFrame: 30 seconds
measure: Correlation of perfusion with quantity of smoking/vaping
timeFrame: 30 seconds
Other outcomes:
Locations:
city: Muenster
country: Germany
facility: University Hospital Muenster
state: Nordrhein-Westfalen
Study officials:
affiliation: University Hospital Muenster
name: Andreas Kyriakou, MD
role: PRINCIPAL_INVESTIGATOR
References: