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

NCT03742700 | Completed

• 1 other identifier: KNW/0022/KB1/37/I/17
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

E-cigarette

Keywords

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

Outcome Measures

Primary Outcomes (7)

• O2 saturation

  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.

  pre - post (1 minute after exposure) - post (30 minute after exposure)

• Concentration of nitric oxide (FeNO)

  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).

  pre - post (1 minute after exposure) - post (30 minute after exposure)

• exhaled carbon monoxide (CO)

  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).

  pre - post (1 minute after exposure) - post (30 minute after exposure)

• temperature of exhaled air

  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).

  pre - post (1 minute after exposure) - post (30 minute after exposure)

• spirometric testing

  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.

  pre - post (1 minute after exposure) - post (30 minute after exposure)

• heart rate

  Heart rate was measured in the sitting position, the result of measurement was expressed in beats per minute.

  pre - post (1 minute after exposure) - post (30 minute after exposure)

• blood pressure

  Blood pressure was measured in the sitting position, the result of measurement was expressed in mmHg.

  pre - post (1 minute after exposure) - post (30 minute after exposure)

Study Arms (4)

T-smokers

EXPERIMENTAL

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.

Behavioral: Cigarette smoking

E-smokers

EXPERIMENTAL

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

Behavioral: E-cigarette use

T/E-smokers

EXPERIMENTAL

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

Behavioral: E-cigarette use

Control subjects

PLACEBO COMPARATOR

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

Behavioral: Simulation of the use of e-cigarette

Interventions

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.

T-smokers

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.

E-smokers; T/E-smokers

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).

Control subjects

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- smoking status (cigarette or e-cigarette smoking)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Silesia: lead

Related Links

• E-smoking: Emerging public health problem?

MeSH Terms

Conditions

Vaping; Cigarette Smoking

Interventions

Electronic Nicotine Delivery Systems

Condition Hierarchy (Ancestors)

Smoking; Behavior; Tobacco Smoking; Tobacco Use

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Grzegorz Brożek, MD, PhD

  Department of Epidemiology, School of Medicine in Katowice, Medical University of Silesia in Katowice, Poland

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: 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).
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: November 11, 2018
• First Posted: November 15, 2018
• Study Start: January 1, 2017
• Primary Completion: April 1, 2018
• Study Completion: June 1, 2018
• Last Updated: November 15, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share