Acute Cardiorespiratory Effects of E-cigarette Inhalation

Study Overview
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Brief Summary
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According to the World Health Organization cigarette smoking is today one of the leading single causes of preventable death and morbidity. The electronic cigarette (e-cigarette) has been marketed as a safer alternative to conventional cigarettes, and its global sales continue to grow exponentially each year. Despite growing e-cigarette use, scientific data on health effects are insufficient in some respects and completely lacking in others. Therefore the current study is designed to investigate the effects of active e-cigarette inhalation on the cardiovascular and respiratory systems.

Detailed Description
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It is estimated that 6 million people worldwide lose their lives due to tobacco use yearly. On average, cigarette smokers are estimated to die 10 years earlier than non-smokers. Ischemic heart disease, chronic obstructive pulmonary disease, stroke, respiratory illness, lung cancer and other cancers have all been linked to tobacco use. In recent years the electronic cigarette (e-cigarette) has been introduced to the market as an alternative to traditional cigarette smoking. E-cigarettes have been aggressively marketed as a cheaper, healthier, cleaner alternative to smoking in both advertising and media outlets, primarily targeting women and adolescents. With limited knowledge of e-cigarette vaping health effects in humans it has been challenging for governments and health officials to give advice and regulate the use of this novel product. In the current study investigators aim to investigate acute cardiovascular and respiratory effects after active inhalation of e-cigarette in healthy human subjects.

Official Title
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Acute Health Effects of Exposure to Active E-cigarette Inhalation in Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Other: E-cigarette


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Intermittent/sporadic cigarette smoking Normal clinical examination Normal EKG Normal blood tests Normal lung function Exclusion Criteria: Cardiovascular disease Respiratory disease Systemic or chronic disorders or disease Symptoms of infection or inflammation within 2 weeks of the study BMI≥30 Pregnancy Current habitual cigarette smokers

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nicotine-free e-cigarette<br>Subjects will actively inhale nicotine-free vapor prior to blood samples and various non-invasive cardiopulmonary tests. | Other: E-cigarette<br>* A third generation e-cigarette device will be used with pre-determined temperature, voltage and wattage settings.<br>|
| Active Comparator: Nicotine e-cigarette<br>Subjects will actively inhale nicotine containing vapor prior to blood samples and various non-invasive cardiopulmonary tests. | Other: E-cigarette<br>* A third generation e-cigarette device will be used with pre-determined temperature, voltage and wattage settings.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial Stiffness | Pulse wave analysis (PWA), pulse wave velocity (PWV). Expressed as Pulse wave velocity (m/s) och augmentation index adjusted for pulse 75 (%). | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung function | Assessed using spirometry testing. | 1 day | 
| Cardiovascular biomarkers | Blood samples are taken in order to assess cardiovascular biomarkers using microassay testing. | 1 day | 
| Impulse oscillometry | Non-invasive measurement by which to evaluate large and small airway resistance, and thereby also airflow obstruction. | 1 day | 
| Microcirculation assessment | Microcirculation assessment is performed using the GlycoCheck system. This measures the endothelial cell surface layer non-invasively by applying a clinical videomicroscope to the sublingual arteries. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nicotine, Electronic Cigarette