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

Laser Speckle Contrast Analysis to Evaluate the Influence of the Consumption of Conventional and Electric Cigarettes on Skin Circulation

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.

Study Overview

• Status: Unknown
• Conditions: Smoking; Nicotine Dependence; Vaping
• Intervention / Treatment: Behavioral: Use of nicotine product (smoking/vaping)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 198
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andreas Kyriakou, MD; Phone Number: 00491636915011; Email: andreaskyr93@gmail.com
• Study Contact Backup: Name: Alexander Oberhuber, Univ.-Prof.; Phone Number: 00492518345782; Email: alexander.oberhuber@ukmuenster.-de

Study Locations

• Germany
  • Nordrhein-Westfalen
    • Muenster, Nordrhein-Westfalen, Germany, 48149
      • Recruiting
      • University Hospital Muenster
      • Contact: Andreas Kyriakou; Phone Number: 01636915011; Email: andreaskyr93@gmail.com
      • Principal Investigator: Andreas Kyriakou, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Healthy adult non-smokers, smokers, vapers

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No smokers; Healthy subjects who do not consume any nicotine products
Experimental: Smokers/Vapers; Healthy subjects who consume nicotine products	Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of perfusion with age	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.	30 seconds
Correlation of perfusion with gender	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.	30 seconds
Correlation of perfusion with quantity of smoking/vaping	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.	30 seconds

Collaborators and Investigators

• Sponsor: University Hospital Muenster
• Investigators: Principal Investigator: Andreas Kyriakou, MD, University Hospital Muenster

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2020
• Primary Completion (Anticipated): May 30, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: November 15, 2020
• First Submitted That Met QC Criteria: November 22, 2020
• First Posted (Actual): November 27, 2020

Study Record Updates

• Last Update Posted (Actual): November 27, 2020
• Last Update Submitted That Met QC Criteria: November 22, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Smoking; Nicotine; Vaping; Perfusion; Laser Speckle Contrast Analysis; Laser Doppler Camera
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: Laser Doppler Camera Study 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No