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

Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04645914
• Other study ID #: Laser Doppler Camera Study 1
• Status: Recruiting
• Phase: N/A
• Start date: July 2, 2020
• Est. completion date: December 1, 2022

Study information

• Verified date: November 2020
• Source: University Hospital Muenster
• Contact: Andreas Kyriakou, MD
• Phone: 00491636915011
• Email: andreaskyr93[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 198
• Est. completion date: December 1, 2022
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Healthy adult non-smokers, smokers, vapers

Exclusion Criteria:

• Adults with cardiopulmonary diseases

• Pregnant women

• Adults that participating in other surveys

Related Conditions & MeSH terms

• Nicotine Dependence
• Smoking
• Tobacco Use Disorder
• Vaping

Intervention

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

Locations

Country	Name	City	State
Germany	University Hospital Muenster	Muenster	Nordrhein-Westfalen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Muenster

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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