Tobacco; Use, Harmful
Conditions
Keywords
tobacco, cardiovascular system, sympathetic nervous system
Brief summary
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.
Interventions
OTHERBaseline
measurement of baseline hemodynamic parameters
DEVICEe-cigarette without nicotine
measurement hemodynamic parameters during smoking e-cigarette without nicotine
DEVICEe-cigarette with nicotine
measurement hemodynamic parameters smoking e-cigarette with nicotine
DEVICEtraditional cigarette
measurement hemodynamic parameters smoking traditional cigarette
Sponsors
Medical University of Warsaw
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate variability | through study completion, an average of 1 year | RR intervals in ms, very low frequency (VLF), low frequency (LF), and high frequency (HF) components - ms2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate | through study completion, an average of 1 year | beats/min |
| Blood pressure variability | through study completion, an average of 1 year | mm Hg |
| Puls wave velocity | through study completion, an average of 1 year | m/s |
| Stroke Volume | through study completion, an average of 1 year | ml |
| Systolic, diastolic, mean blood pressure | through study completion, an average of 1 year | mm Hg |
| Total Peripheral Resistance | through study completion, an average of 1 year | dyn\*sec/cm5 |
| Baroreceptor reflex sensitivity | through study completion, an average of 1 year | ms/mm Hg |
| Muscle sympathetic nerve activity | through study completion, an average of 1 year | bursts/min, bursts/100 beats/min |
| Cardiac output | through study completion, an average of 1 year | ml/min |
Countries
Poland
Contacts
Primary ContactPaweł Dziliński, M.D.
Backup ContactJacek Lewandowski, M.D., Ph.D.
Outcome results
None listed