An interventional study of Baseline and e-cigarette without nicotine in Tobacco; Use, Harmful, sponsored by Medical University of Warsaw. Status unknown at 1 site in Poland. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-01-31.
Sponsored by Medical University of Warsaw · Not applicable, Interventional, and Prevention
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.
Medical University of Warsaw is the lead sponsor of 316 studies on the registry; 87 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Device: e-cigarette without nicotine · Device: e-cigarette with nicotine · Device: traditional cigarette
measurement of baseline hemodynamic parameters
measurement hemodynamic parameters during smoking e-cigarette without nicotine
measurement hemodynamic parameters smoking e-cigarette with nicotine
measurement hemodynamic parameters smoking traditional cigarette
Heart rate variability
RR intervals in ms, very low frequency (VLF), low frequency (LF), and high frequency (HF) components - ms2
Time frame: through study completion, an average of 1 year
Systolic, diastolic, mean blood pressure
mm Hg
Time frame: through study completion, an average of 1 year
Heart rate
beats/min
Time frame: through study completion, an average of 1 year
Blood pressure variability
mm Hg
Time frame: through study completion, an average of 1 year
Puls wave velocity
m/s
Time frame: through study completion, an average of 1 year
Stroke Volume
ml
Time frame: through study completion, an average of 1 year
Cardiac output
ml/min
Time frame: through study completion, an average of 1 year
Total Peripheral Resistance
dyn\*sec/cm5
Time frame: through study completion, an average of 1 year
Baroreceptor reflex sensitivity
ms/mm Hg
Time frame: through study completion, an average of 1 year
Muscle sympathetic nerve activity
bursts/min, bursts/100 beats/min
Time frame: through study completion, an average of 1 year
Plan to share: No
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Medical University of Warsaw