Vaping Adverse Lung and Heart Events Cohort
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLaval University
About this trial
This prospective study assesses the pulmonary and cardiovascular effets of vaping in adult electronic cigarette users with biannual visits and a 5-year follow-up.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 18 years or older
Daily electronic cigarette user
No respiratory infection in the 4 weeks before a visit
Disqualifiers
Women who are pregnant or breast-feeding.
Trial population
We seek to recruit 250 volunteers from the community with twice-a-year visits for a 5-year follow-up. We will recruit healthy volunteers as well as volunteers who have been previously diagnosed with chronic illness.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Vaping
Other interventionParticipants use their vaping products at their own discretion and their intake is monitored via questionnaires.
Treatment groups
250 Participants
are divided into 1 treatment groupGroup A: Daily electronic cigarette users1 intervention
Trial outcomes
Primary outcomes
1
Number of participants who vape daily with impaired lung volumes.
Participants will perform plethysmography assessments to measure changes in lung volumes. Data will be expressed as a percentage of predicted values.
Time frame
Every 6 months for 5 years2
Number of participants who vape daily with impaired lung diffusion capacity.
Participants will perform diffusion capacity of the lung for carbon monoxide (DLCO) measures to assess changes in lung diffusion capacity. Data will be expressed as a percentage of predicted values.
Time frame
Every 6 months for 5 years3
Number of participants who vape daily with impaired spirometry.
Participants will perform spirometry tests measures to assess changes in forced expiratory lung volumes. Data will be expressed as a percentage of predicted values.
Time frame
Every 6 months for 5 years4
Number of participants who vape daily with airway hyperresponsiveness.
Participants will perform methacholine provocation challenge measures to assess changes in airway hyperresponsiveness. Data will be expressed as the methacholine concentration inducing a fall of 20% of forced expiratory volume in the first second assessed (PC20).
Time frame
Every 6 months for 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Laval University
Lead sponsor
Ministere de la Sante et des Services Sociaux
Collaborator
Source ClinicalTrials.gov