The Influence of Electronic and Traditional Cigarettes Smoking on Hemodynamic Parameters

Study Overview
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Brief Summary
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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.

Official Title
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The Influence of Electronic and Traditional Cigarettes Smoking on Hemodynamic Parameters and Sympathetic Nerves Activity in Healthy People

Conditions
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Tobacco; Use, Harmful

Intervention / Treatment
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* Other: Baseline
* Device: e-cigarette without nicotine
* Device: e-cigarette with nicotine
* Device: traditional cigarette


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Investigated group<br>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 | Other: Baseline<br>* measurement of baseline hemodynamic parameters<br>Device: e-cigarette without nicotine<br>* measurement hemodynamic parameters during smoking e-cigarette without nicotine<br>Device: e-cigarette with nicotine<br>* measurement hemodynamic parameters smoking e-cigarette with nicotine<br>Device: traditional cigarette<br>* measurement hemodynamic parameters smoking traditional cigarette<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate variability | RR intervals in ms, very low frequency (VLF), low frequency (LF), and high frequency (HF) components - ms2 | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic, diastolic, mean blood pressure | mm Hg | through study completion, an average of 1 year | 
| Heart rate | beats/min | through study completion, an average of 1 year | 
| Blood pressure variability | mm Hg | through study completion, an average of 1 year | 
| Puls wave velocity | m/s | through study completion, an average of 1 year | 
| Stroke Volume | ml | through study completion, an average of 1 year | 
| Cardiac output | ml/min | through study completion, an average of 1 year | 
| Total Peripheral Resistance | dyn*sec/cm5 | through study completion, an average of 1 year | 
| Baroreceptor reflex sensitivity | ms/mm Hg | through study completion, an average of 1 year | 
| Muscle sympathetic nerve activity | bursts/min, bursts/100 beats/min | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tobacco, cardiovascular system, sympathetic nervous system