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

University Hospital Muenster

Status: Unknown

Conditions: Nicotine Dependence; Vaping; Smoking

Treatments: Behavioral: Use of nicotine product (smoking/vaping)

Study type: Interventional

Funder types: Other

Identifiers

NCT04645914

Laser Doppler Camera Study 1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 198 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Healthy adult non-smokers, smokers, vapers

Exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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198 participants in 2 patient groups

No smokers

No Intervention group

Description:

Healthy subjects who do not consume any nicotine products

Smokers/Vapers

Experimental group

Description:

Healthy subjects who consume nicotine products

Treatment:

Behavioral: Use of nicotine product (smoking/vaping)