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

NCT ID: NCT04645914

Last Updated: 2020-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-02

Study Completion Date

2022-12-01

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.

Conditions

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Nicotine Dependence Vaping Smoking

Keywords

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Perfusion Laser Speckle Contrast Analysis Laser Doppler Camera Nicotine Smoking Vaping

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two groups : consumers of cigarettes/e-cigarettes and non consumers of cigarettes/e-cigarettes
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Double blind through randomization

Study Groups

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No smokers

Healthy subjects who do not consume any nicotine products

Group Type NO_INTERVENTION

No interventions assigned to this group

Smokers/Vapers

Healthy subjects who consume nicotine products

Group Type EXPERIMENTAL

Use of nicotine product (smoking/vaping)

Intervention Type BEHAVIORAL

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

Interventions

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Use of nicotine product (smoking/vaping)

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

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital Muenster

OTHER

Sponsor Role lead

Responsible Party

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Andreas Kyriakou

Vacular Surgery Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andreas Kyriakou, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Muenster

Locations

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University Hospital Muenster

Münster, North Rhine-Westphalia, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Andreas Kyriakou, MD

Role: CONTACT

Phone: 00491636915011

Email: [email protected]

Alexander Oberhuber, Univ.-Prof.

Role: CONTACT

Phone: 00492518345782

Email: [email protected]

Facility Contacts

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Andreas Kyriakou

Role: primary

Other Identifiers

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Laser Doppler Camera Study 1

Identifier Type: -

Identifier Source: org_study_id