NCT03037775

The Influence of Electronic and Traditional Cigarettes Smoking on Hemodynamic Parameters

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Medical University of Warsaw · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Tobacco; Use, Harmful

Interventions

Type	Name	Description
OTHER	Baseline	measurement of baseline hemodynamic parameters
DEVICE	e-cigarette without nicotine	measurement hemodynamic parameters during smoking e-cigarette without nicotine
DEVICE	e-cigarette with nicotine	measurement hemodynamic parameters smoking e-cigarette with nicotine
DEVICE	traditional cigarette	measurement hemodynamic parameters smoking traditional cigarette

Timeline

• Start date: 2015-06-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2017-01-31
• Last updated: 2017-01-31

Locations

1 site across 1 country: Poland