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Completed

NCT Number: NCT03742700

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

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.

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Key information

Conditions

E-cigarette Behavior Cigarette Smoking Smoking Tobacco Smoking Tobacco Use Vaping

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cigarette Smoking

Behavioral

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.

E-cigarette use

Behavioral

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

Simulation of the use of e-cigarette

Behavioral

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

Primary outcomes

  1. O2 saturation

    Time frame: pre - 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.

  2. Concentration of nitric oxide (FeNO)

    Time frame: 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).

  3. exhaled carbon monoxide (CO)

    Time frame: 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).

  4. temperature of exhaled air

    Time frame: pre - 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).

  5. spirometric testing

    Time frame: pre - 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.

  6. heart rate

    Time frame: pre - 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.

  7. blood pressure

    Time frame: pre - 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.

Sponsors and collaborators

Lead sponsor

Medical University of Silesia

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 15, 2018
Registry last updated
Nov 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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