Acute Health Effects of Short-term Use of E-cigarettes on Pulmonary and Cardiovascular System

M

Medical University of Silesia

Status

Completed

Conditions

E-cigarette

Treatments

Behavioral: Simulation of the use of e-cigarette
Behavioral: E-cigarette use
Behavioral: Cigarette smoking

Study type

Interventional

Funder types

Other

Identifiers

NCT03742700
KNW/0022/KB1/37/I/17

Details and patient eligibility

About

The goal of our study was to assess acute, short term respiratory (airflow, FeNO, O2 saturation, exhaled air temperature) and cardiovascular (heart rate, blood pressure) responses to smoking an e-cigarette in exclusive e-smokers and dual users and to compare these effects with responses to smoking a tobacco-cigarette in exclusive tobacco smokers.

Enrollment

120 patients

Sex

All

Ages

18 to 30 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

- smoking status (cigarette or e-cigarette smoking)

Exclusion criteria

  • occurrence of any chronic diseases,
  • history of lung conditions (eg.: asthma or bronchial hyperactivity in childhood),
  • presence of any allergic diseases,
  • medication intake within the last 2 weeks,
  • acute illnesses or infections in the last 2 weeks,
  • influenza vaccination in the last 2 weeks,
  • or current pregnancy or lactation.

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

120 participants in 4 patient groups, including a placebo group

T-smokers
Experimental group
Description:
T-smokers were asked to smoke a cigarette of one of the popular brands (0.6mg nicotine per one cigarette) according to their everyday habits.
Treatment:
Behavioral: Cigarette smoking
E-smokers
Experimental group
Description:
E-smokers were instructed to use e-cigarettes (12 mg/ml nicotine) in accordance with everyday habits for 5 minutes.
Treatment:
Behavioral: E-cigarette use
T/E-smokers
Experimental group
Description:
T/E-smokers (dual users) were instructed to use e-cigarettes (12 mg/ml nicotine) in accordance with everyday habits for 5 minutes.
Treatment:
Behavioral: E-cigarette use
Control subjects
Placebo Comparator group
Description:
The control subjects were asked to simulate the use of e-cigarettes (a device without e-liquid where aerosol was not created or inhaled).
Treatment:
Behavioral: Simulation of the use of e-cigarette

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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