The Influence of Electronic and Traditional Cigarettes Smoking on Hemodynamic Parameters

Not Applicable

• Conditions: Tobacco; Use, Harmful
• Interventions: Other: Baseline; Device: e-cigarette without nicotine; Device: e-cigarette with nicotine; Device: traditional cigarette

• Registration Number: NCT03037775
• Lead Sponsor: Medical University of Warsaw

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Status Verified: 2017-01
• Study First Submitted: 2017-01-11
• Study First Submitted QC: 2017-01-27
• Last Update Submitted: 2017-01-27
• Study First Posted: 2017-01-31
• Last Update Posted: 2017-01-31
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Investigated group	traditional cigarette	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
Investigated group	e-cigarette without nicotine	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
Investigated group	Baseline	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
Investigated group	e-cigarette with nicotine	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Systolic, diastolic, mean blood pressure	through study completion, an average of 1 year	mm Hg
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
Cardiac output	through study completion, an average of 1 year	ml/min
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

Trial Locations

Locations (1)

Warszawski Uniwersytet Medyczny; 🇵🇱 Warszawa, Mazowieckie, Poland