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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03742700
Enrollment
120
Registered
2018-11-15
Start date
2017-01-31
Completion date
2018-06-30
Last updated
2018-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

E-cigarette

Keywords

e-cigarette, health effects, cigarette smoking, exhaled nitric oxide, pulmonary function tests

Brief summary

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.

Interventions

BEHAVIORALCigarette smoking

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.

BEHAVIORALE-cigarette use

E-smokers and dual users were instructed to use e-cigarettes (12 mg/ml nicotine) in accordance with everyday habits for 5 minutes.

BEHAVIORALSimulation of the use of e-cigarette

The control subjects were asked to simulate the use of e-cigarettes (a device without e-liquid where aerosol was not created or inhaled).

Sponsors

Medical University of Silesia
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Masking description

Subjects were divided into 4 groups (n=30 each) based on their self-declared smoking status: control (C), tobacco cigarette smokers (T-Smokers), exclusive e-cigarette users (E-Smokers) and dual users (T/E-Smokers).

Intervention model description

This was a laboratory-based intervention study: pre-post-post

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
O2 saturationpre - post (1 minute after exposure) - post (30 minute after exposure)The O2 measurement was made in the sitting position using the PULSOX 2 electronic pulse meter. The result was recorded 15 seconds after the start of the measurement.
Concentration of nitric oxide (FeNO)pre - post (1 minute after exposure) - post (30 minute after exposure)FeNO measurements were made using the standard procedure in the sitting position with a clip attached to the nose using a NIOX MINO device for measuring fractional exhaled nitric oxide (FeNO). Subjects were instructed to breathe as deeply as possible through the mouthpiece to achieve maximum lung filling and then to exhale 50ml/sec for 10s. The measured FeNO values were expressed in ppb (parts per billion).
exhaled carbon monoxide (CO)pre - post (1 minute after exposure) - post (30 minute after exposure)During the measurement, requirements regarding the length and intensity of the exhalation were taken into account. The measurements were made using the PiCo Smokylyzer device. The measured CO levels were expressed in ppm (parts per million).
temperature of exhaled airpre - post (1 minute after exposure) - post (30 minute after exposure)The measurement was made using the standard procedure in the sitting position using an X-Halo Breath Thermometer \[20\]. Respondents were instructed to breathe according to the procedure recommended by the device manufacturer. The temperature of exhaled air was expressed in Celsius degrees (°C).
spirometric testingpre - post (1 minute after exposure) - post (30 minute after exposure)Airflow and lung volume were measured in the sitting position with a noseclip according to the ATS/ERS guidelines. The measurements were made using the EasyOne 2001 spirometer and included FEV1, FVC, FEV1% FVC, PEF and MEF75,50,25. Expiratory maneuvers were repeated until a minimum of three technically correct, repeatable measurements were obtained.
heart ratepre - post (1 minute after exposure) - post (30 minute after exposure)Heart rate was measured in the sitting position, the result of measurement was expressed in beats per minute.
blood pressurepre - post (1 minute after exposure) - post (30 minute after exposure)Blood pressure was measured in the sitting position, the result of measurement was expressed in mmHg.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026