Acute Cardiorespiratory Effects of E-cigarette Inhalation

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: E-cigarette

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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Umeå, Sweden
    • Dept of Medicine, Lung and Allergy section, University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Umeå University
• Collaborators: Karolinska Institutet

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: September 8, 2016
• First Submitted That Met QC Criteria: September 13, 2016
• First Posted (Estimate): September 14, 2016

Study Record Updates

• Last Update Posted (Actual): October 4, 2018
• Last Update Submitted That Met QC Criteria: October 3, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Nicotine; Electronic Cigarette
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: Umu-104-31

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided