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

Medical University of Silesia

Status: Completed

Conditions: E-cigarette

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

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)

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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