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OpenTrials
Completed

NCT Number: NCT02899234

Acute Cardiorespiratory Effects of E-cigarette Inhalation

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept of Medicine, Lung and Allergy section, University Hospital

Umeå, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

E-Cigarette

Other

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

Primary outcomes

  1. Arterial Stiffness

    Time frame: 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 outcomes

  1. Lung function

    Time frame: 1 day

    Assessed using spirometry testing.

  2. Cardiovascular biomarkers

    Time frame: 1 day

    Blood samples are taken in order to assess cardiovascular biomarkers using microassay testing.

  3. Impulse oscillometry

    Time frame: 1 day

    Non-invasive measurement by which to evaluate large and small airway resistance, and thereby also airflow obstruction.

  4. Microcirculation assessment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Collaborators

  • Karolinska Institutet

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 14, 2016
Registry last updated
Oct 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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