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.

Study Overview

• Status: Completed
• Conditions: E-cigarette
• Intervention / Treatment: Behavioral: Cigarette smoking; Behavioral: E-cigarette use; Behavioral: Simulation of the use of e-cigarette

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NON_RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: T-smokers; 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; 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.
Experimental: E-smokers; E-smokers were instructed to use e-cigarettes (12 mg/ml nicotine) in accordance with everyday habits for 5 minutes.	Behavioral: E-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.
Experimental: T/E-smokers; 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; E-smokers and dual users were instructed to use e-cigarettes (12 mg/ml nicotine) in accordance with everyday habits for 5 minutes.
Placebo Comparator: Control subjects; 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; The control subjects were asked to simulate the use of e-cigarettes (a device without e-liquid where aerosol was not created or inhaled).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Medical University of Silesia
• Investigators: Study Director: Grzegorz Brożek, MD, PhD, Department of Epidemiology, School of Medicine in Katowice, Medical University of Silesia in Katowice, Poland

Publications and helpful links

Helpful Links

• E-smoking: Emerging public health problem?

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: November 11, 2018
• First Submitted That Met QC Criteria: November 14, 2018
• First Posted (Actual): November 15, 2018

Study Record Updates

• Last Update Posted (Actual): November 15, 2018
• Last Update Submitted That Met QC Criteria: November 14, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: e-cigarette; cigarette smoking; exhaled nitric oxide; pulmonary function tests; health effects
• Other Study ID Numbers: KNW/0022/KB1/37/I/17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No