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

Not Applicable

Completed

• Conditions: E-cigarette
• Interventions: Behavioral: E-cigarette use; Behavioral: Simulation of the use of e-cigarette; Behavioral: Cigarette smoking

• Registration Number: NCT03742700
• Lead Sponsor: Medical University of Silesia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01
• Primary Completion: 2018-04
• Study Completion: 2018-06
• Status Verified: 2018-11
• Study First Submitted: 2018-11-11
• Study First Submitted QC: 2018-11-14
• Last Update Submitted: 2018-11-14
• Study First Posted: 2018-11-15
• Last Update Posted: 2018-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
temperature of exhaled air	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).
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).
spirometric testing	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.
heart rate	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.
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).
O2 saturation	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.
blood pressure	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.