Acute Cardiorespiratory Effects of E-cigarette Inhalation

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02899234

Enrollment

Registered

2016-09-14

Start date

2016-09-30

Completion date

2018-06-30

Last updated

2018-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Nicotine, Electronic Cigarette

Brief summary

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

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.

Interventions

OTHERE-cigarette

A third generation e-cigarette device will be used with pre-determined temperature, voltage and wattage settings.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Lung function	1 day	Assessed using spirometry testing.
Cardiovascular biomarkers	1 day	Blood samples are taken in order to assess cardiovascular biomarkers using microassay testing.
Impulse oscillometry	1 day	Non-invasive measurement by which to evaluate large and small airway resistance, and thereby also airflow obstruction.
Microcirculation assessment	1 day	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.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026