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

NCT04645914 | Unknown

• 1 other identifier: Laser Doppler Camera Study 1
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

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.

Conditions

Nicotine Dependence; Vaping; Smoking

Keywords

Perfusion; Laser Speckle Contrast Analysis; Laser Doppler Camera; Nicotine; Smoking; Vaping

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Correlation of perfusion with age

  30 seconds

• Correlation of perfusion with gender

  30 seconds

• Correlation of perfusion with quantity of smoking/vaping

  30 seconds

Study Arms (2)

No smokers

NO INTERVENTION

Healthy subjects who do not consume any nicotine products

Smokers/Vapers

EXPERIMENTAL

Healthy subjects who consume nicotine products

Behavioral: Use of nicotine product (smoking/vaping)

Interventions

Use of nicotine product (smoking/vaping) 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

Smokers/Vapers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adult non-smokers, smokers, vapers

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Muenster: lead

Study Sites (1)

University Hospital Muenster

Münster, North Rhine-Westphalia, 48149, Germany

RECRUITING

MeSH Terms

Conditions

Tobacco Use Disorder; Vaping; Smoking

Interventions

Smoking Devices; Electronic Nicotine Delivery Systems

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Andreas Kyriakou, MD

  University Hospital Muenster

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andreas Kyriakou, MD

CONTACT

00491636915011; andreaskyr93@gmail.com

Alexander Oberhuber, Univ.-Prof.

CONTACT

00492518345782; alexander.oberhuber@ukmuenster.-de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind through randomization
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vacular Surgery Resident

Model Details: Two groups : consumers of cigarettes/e-cigarettes and non consumers of cigarettes/e-cigarettes

Study Record Dates

• First Submitted: November 15, 2020
• First Posted: November 27, 2020
• Study Start: July 2, 2020
• Primary Completion: May 30, 2022
• Study Completion: December 1, 2022
• Last Updated: November 27, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)