The Influence of Electronic and Traditional Cigarettes Smoking on Hemodynamic Parameters (EPAPHemo)

Medical University of Warsaw

Status: Unknown

Conditions: Tobacco; Use, Harmful

Treatments: Device: e-cigarette without nicotine; Device: traditional cigarette; Other: Baseline; Device: e-cigarette with nicotine

Study type: Interventional

Funder types: Other

Identifiers

NCT03037775

EPAPHemo

Details and patient eligibility

About

It is intended to examine 50 healthy volunteers aged 18 - 60 years. 12-hour abstinence from tobacco smoke, alcohol or coffee before the experiment will be required. The exclusion criteria are medical history of stroke, coronary artery disease, chronic heart failure, hypertension, peripheral vascular disease, atrial fibrillation, polyneuropathy, obesity (BMI> 30 kg/m2), the current active disease (eg. viral infection). Test subjects will actively inhale for 10 minutes tobacco or the e-cigarette smoke with nicotine fluid (18 mg/ml) or fluid without nicotine for 10 minutes. The study protocol involves random allocation to groups exposed to electronic or traditional cigarette smoke in cross-over scheme. The primary endpoint is the maximum change in heart rate compared to mean values prior to exposure. Secondary end points is the maximum change in the measured parameters (hemodynamic and autonomic values) compared to the average values before exposure. The measurements will be performed using the Task Force Monitor system for non-invasive measurement of hemodynamic parameters and the assessment of autonomic function. Adrenergic activity will be tested with microneurography. A periodic analysis is planned after examining 15 and 35 patients.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy volunteers aged 18 - 60 years
• 12-hour abstinence from tobacco smoke, alcohol or coffee before the experiment will be required

Exclusion criteria

• history of stroke, coronary artery disease, chronic heart failure, hypertension, peripheral vascular disease, atrial fibrillation, polyneuropathy, obesity (BMI> 30 kg/m2), the current active disease (eg. viral infection).

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Investigated group

Other group

Description:

Subjects underwent procedures: hemodynamic indices will be measured at baseline and during 1/ e-cigarette without nicotine smoking, 2/ e-cigarette with nicotine and during 3/ traditional cigarette smoking in random order

Treatment:

Device: traditional cigarette

Other: Baseline

Device: e-cigarette with nicotine

Device: e-cigarette without nicotine