Electronic Cigarette UseNCT07924007
Cardiopulmonary Complications of Electronic Cigarettes
A study testing Lower body positive and negative pressure and Exercise in people with Electronic Cigarette Use and Cannabis Use, run by University of Alberta at 1 site in Canada.
Trial summary
The study aims to look at whether changes in the blood vessels of the lungs are related to how well electronic cigarette users tolerate exercise. It also aims to investigate whether increasing blood flow to the lungs can improve the reduced ability of E-CIG users' lungs to transfer oxygen into the bloodstream. Read more about this study
- Who is it for?
- Ages 12 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Electronic Cigarette Use, Cannabis Use
- What is being tested?
- Lower body positive and negative pressure and Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2026to 30 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Adolescent Cohort:
- Participants aged ≥12 and <18 years
- Non-smoking and Non-E-CIG Use: <100 lifetime cigarettes and < 200 E-CIG puffs
- E-CIG Use Only: currently using E-CIGs every day or some days
- Cannabis Use: cannabis smoking history of > 1 joint-year
- Combined E-CIG and Cannabis Use: adolescents who meet both #3 and #4
Show all 12Show fewer
- Adult Cohort:
- Participants aged 18-40 years
- Non-smoking and Non-E-CIG Use: <100 lifetime cigarettes and < 200 E-CIG puffs
- E-CIG Use Only: currently using E-CIGs every day or some days
- Cannabis Use: cannabis smoking history of > 1 joint-year
- Combined E-CIG and Cannabis Use: adults who meet both #3 and #4
Who cannot join
- Contraindication to pulmonary function testing (i.e. recent thoracic or abdominal surgery, aneurysms, cardiovascular instability)
- Unable to provide informed consent
- Currently undergoing treatment for lung cancer
- Cigarette smoking in the past 6 months
- Physician-diagnosed chronic lung disease (e.g. cystic fibrosis, asthma, primary ciliary dyskinesia, bronchopulmonary dysplasia) (adolescent arm only)
- Self-reported premature infancy, referring to individuals who were born premature (born before the 37th week of pregnancy). Previous literature and work in our lab have shown that lung development is blunted in these individuals, and we are therefore excluding those born prematurely so that underdeveloped lungs do not impact the findings of the present study.
- Pregnancy. To confirm this, women not using contraception will be given a pregnancy test prior to starting the study. Pregnancy presents additional complications and may confound the results of the study; therefore, pregnant women will be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Clinical Physiology Laboratory
Edmonton, Alberta, T6G2R3
Desi P Fuhr, MSc, 7804921121, fuhr@ualberta.ca
Michael K Stickland, PhD, 7804923995, michael.stickland@ualberta.ca
About this study
The study aims to look at whether changes in the blood vessels of the lungs are related to how well electronic cigarette users tolerate exercise. It also aims to investigate whether increasing blood flow to the lungs can improve the reduced ability of E-CIG users' lungs to transfer oxygen into the bloodstream.
Read the detailed description
Background:
The invention of electronic cigarettes (E-CIGs) in 2003 upended the trajectory of a decades-long public health campaign against cigarette smoking. Promoted as a safer method of inhaling nicotine compared to cigarettes and as smoking cessation tools, E-CIGs have substantially grown in popularity with rates of uptake now exceeding those of cigarette smoking. Surveys estimate that 5.8% of Canadians 15 years and older have used E-CIGs in the last 30 days. Young Canadians appear particularly susceptible: 13.6% of youths aged 15-19 and 19.7% aged 20-24 report past 30 day E-CIG use. Despite this rapid growth, questions remain as to their long-term safety. In 2019, an outbreak in the United States of acute lung injury related to E-CIGs (later termed E-cigarette or Vaping Use-Associated Lung Injury or EVALI) served as a warning that these devices were not benign. As Canadians increasingly reach for E-CIGs, especially at younger ages and not just for the purposes of smoking cessation, greater clarity into the pulmonary toxicities of E-CIG use is urgently needed.
E-CIG use has been linked to cardiopulmonary risks with potential long-term consequences for health. Even mild reductions in cardiopulmonary function during young adulthood are associated with increased risk of disease, morbidity, and all-cause mortality, underscoring the importance of protecting cardiopulmonary health. Recent work has shown that E-CIG use is associated with reduced exercise capacity (V̇O2peak), increased exertional dyspnea and greater ventilatory inefficiency. Additionally, emerging evidence linking E-CIG use with greater ventilation/perfusion heterogeneity and blunted pulmonary diffusing capacity for carbon monoxide (DLCO) recruitment during a volume-loading challenge suggests the presence of pulmonary vascular dysfunction. However, the mechanisms behind these findings remain largely unknown.
DLCO is a pivotal component of gas exchange and acid-base balance. Indeed, increases in lung diffusing capacity are critical to meeting the elevated metabolic demands during exercise and subsequently preventing a diffusion limitation, excessive increases in alveolar-arterial oxygen difference and possibly exercise induced arterial hypoxemia. Furthermore, reduced DLCO in those with respiratory diseases, such as chronic obstructive pulmonary disease, contributes to exercise intolerance and arterial hypoxemia. Physiological stressors such as exercise and controlled alterations in central blood volume (CBV) provide a means of challenging the cardiopulmonary system to reveal early dysfunction. Exercise increases cardiac output and pulmonary blood flow, requiring proportional increases in DLCO secondary to its components pulmonary capillary blood volume (VC) and membrane diffusing capacity (DM) to maintain efficient gas exchange. Similarly, lower body positive and negative pressure (LBPP/LBNP) transiently manipulate CBV, enabling assessment of pulmonary vascular responsiveness under controlled loading conditions. Evaluating DLCO during these stressors may therefore uncover abnormalities that are not detectable at rest, providing novel insight into the early pulmonary consequences of chronic E-CIG use. Additionally, as many individuals also consume cannabis, the investigators will also recruit a cannabis use only and a combined E-CIG and cannabis group.
Purposes/Objectives and Hypotheses:
The purpose of the current study is to:
- Describe the relationship between pulmonary vascular structural and functional parameters with exercise tolerance in E-CIG users, and
- Examine if blunted resting DLCO recruitment in E-CIG users can be normalized by increasing pulmonary blood volume through LBPP.
The investigators hypothesize that:
- E-CIG users will show a blunted DLCO response to exercise, particularly in females, and that impaired pulmonary vascular structure/function is associated with exercise intolerance in E-CIG users, and
- Increasing central blood volume via LBPP will normalize resting DLCO in E-CIG users.
Participant Selection:
The study design includes a cohort of individuals aged 12-40 years who have consented to be contacted from previous studies.
Inclusion criteria for the adolescent and adult cohorts are as follows:
Adolescent Cohort:
- Participants aged ≥12 and <18 years
- Control group: < 100 lifetime cigarettes, < 200 lifetime E-CIG puffs, and no cannabis exposure
- E-CIG Use Only: currently using E-CIGs every day or some days
- Cannabis Use: cannabis smoking history of > 1 joint-year
- Combined E-CIG and Cannabis Use: adolescents who meet both #3 and #4
Adult Cohort:
- Participants aged 18-40 years
- Control group: < 100 lifetime cigarettes, < 200 lifetime E-CIG puffs, and no cannabis exposure
- E-CIG Use Only: currently using E-CIGs every day or some days
- Cannabis Use: cannabis smoking history of > 1 joint-year
- Combined E-CIG and Cannabis Use: adults who meet both #3 and #4
Research Method/Procedures:
All visits will happen on separate days with at least 24 hours between visits.
Visit 1: Screening:
The participant will undergo a venous blood draw to measure cotinine and THC, and complete detailed questionnaires regarding demographic, medical, E-CIG and other substance use. The investigators will then perform pulmonary function tests on each participant. Finally, the participant will complete a graded exercise test (V̇O2max, expired gas analyses, operating lung volumes) on an upright cycle ergometer to volitional exhaustion with measurement of heart rate and blood pressure. Evaluation of dyspnea including intensity and unpleasantness will be performed at each workload. Further, reasons for test termination, dyspnea, and qualitative descriptors of dyspnea will be evaluated at peak exercise. Hemoglobin (Hb) concentration will be measured via finger prick prior to and following completion of exercise testing.
At the end of the visit, participants will be provided with an activity monitor to quantify physical activity. They will be instructed to wear the device 24-hours per day for seven consecutive days and return it to the research coordinator at the end of the monitoring period.
Fitbit wear compliance will be monitored by reviewing the recorded activity data and wear time following the 7-day monitoring period. The Fitbit data allows for clear differentiation of when the device is not worn. Participants will be instructed to wear the Fitbit for the duration of the monitoring period, except when removal is necessary (e.g., charging, water-related activities, contact sports). Brief periods of non-wear will be permitted, and participants will be instructed to put the device back on as soon as possible. The research team will review the data for periods of non-wear or missing data and will assess data completeness and integrity prior to analysis.
Visit 2: DLCO with Rest and Exercise:
Exercise will be used as a physiological stressor to increase central blood volume. The participant will perform DLCO maneuvers at rest and during exercise at varying exercise intensities between ~20%-100% of their V̇O2max. Participants will also be equipped with a continuous blood pressure monitor, a brachial blood pressure cuff, an electrocardiogram, and a thoracic impedance device. At each stage participants will also breathe on a mouthpiece for two minutes to collect metabolic data: ventilation (V̇E), oxygen consumption (V̇O2), and carbon dioxide production (V̇CO2). Cardiovascular parameters (blood pressure, peripheral venous pressure, heart rate, thoracic impedance) will be measured continuously. Hb via finger prick will also be measured at each intensity.
As per recommendations , participants will perform standard DLCO breath-hold maneuvers for 6 seconds, and maneuvers will be performed twice at each intensity. A washout period of at least 4 minutes at rest and 2 minutes between each breath hold during exercise will be completed to ensure adequate recovery and blood gas equilibration. Participants will not complete more than 15 DLCO breath holds during each experimental visit.
Visit 3: Central Blood Volume Manipulation and DLCO:
The participant will perform the DLCO test at various levels of LBNP/LBPP ranging from -80 mmHg to +40 mmHg. Changes in central blood volume during LBNP are equivalent to standing upright (-80 mmHg LBNP), and changes in central blood volume during LBPP are equivalent to lying down with the participant's feet above their head (+40 mmHg LBPP). For the LBNP/LBPP trials, participants will lie supine with their lower body (from the iliac crest to their toes) inside the pressure chamber. The participant's lower body will be sealed within the differential pressure chamber using a neoprene skirt to prevent any air leakage from the insides of the chamber. Negative and positive pressures are induced by a vacuum pump that either reduces or increases atmospheric pressure inside the chamber in a controlled and precise manner. The vacuum pump is controlled by a trained member of the research team, and chamber pressure is continuously monitored via a digital manometer.
Participants will be equipped with a continuous blood pressure monitor, a brachial blood pressure cuff, an electrocardiogram, and a thoracic impedance device. Each stage of LBPP/LBNP will begin with two minutes of stabilization followed by two DLCO breath-hold maneuvers. At each stage, participants will also breathe on a mouthpiece for two minutes to collect metabolic data, and oscillometry measurements will be completed twice per stage. Cardiovascular parameters will be measured continuously. Hb via finger prick will be measured prior to the first pressure stage and again at the transition between LBNP and LBPP conditions.
Participants will not complete more than 15 breath holds during the experimental visit. As per recommendations, participants will perform standard DLCO breath-hold maneuvers for 6 seconds, and maneuvers will be performed twice at each stage. A washout period of at least 4 minutes between each breath hold will be completed to ensure adequate recovery and blood gas equilibration.
Visit 4: Ultrasound with Exercise and LBPP/LBNP:
Participants will complete the same interventions as visit 3 (exercise at ~20%-100% of their V̇O2max) and visit 4 (LBNP/LBPP -80 to +40 mmHg). At each stage of exercise and LBNP/LBPP, a trained sonographer will obtain images of the heart via echocardiography.
Visit 5: Blood Volume Measurement Participants from the adult cohort only will undergo a carbon monoxide rebreathe protocol to estimate blood volume. A certified technician will insert an IV catheter into an antecubital vein to collect serial blood samples. While lying supine, participants will inhale a bolus of carbon monoxide (0.7-1.0 mL/kg bodyweight) mixed with 100% oxygen on a rebreathing circuit for two minutes and will then continue to rest for eight additional minutes. Venous blood samples measuring carboxyhemoglobin before the rebreathe and at eight and 10 minutes after the rebreathe will allow the calculation of blood volume.
Visit 6: Computed Tomography:
Participants from the adult cohort only will report to a Medical Imaging Centre for the CT scan. Following a briefing by the Medical Imaging Centre staff, participants will lie supine on the CT scanner and the region of interest in the chest will be obtained. The participant will remain as still as possible and inhale to total lung capacity and hold their breath. During the breath hold, images will be acquired. The participant will then empty their lungs as far as they can and imaging will be repeated.
- Conditions
- Electronic Cigarette Use, Cannabis Use
- Being tested
- Lower body positive and negative pressure, Exercise
- Keywords
- Pulmonary vascular, Exercise capacity, Vape, Vaping, E-cigarette, Electronic cigarette, Cannabis
- Medical subject headings
- Vaping, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lower body positive and negative pressureOther
Primary outcomes will be assessed during graded lower body positive pressure (+10, +20, +30 mmHg) and negative pressure (-15, -30, -45, -60 mmHg).
ExerciseOther
Primary outcomes will be examined at rest and at exercise intensities between ~20%-100% of their V̇O2max.
| Study group | Role | What they receive |
|---|---|---|
| Adult Participants | Experimental | Adult participants will complete all six visits as outlined in the study description. Receives: Other: Lower body positive and negative pressure; Other: Exercise |
| Adolescent Participants | Experimental | Adolescent participants will complete visits 1-4 as outlined in the study description. Receives: Other: Lower body positive and negative pressure; Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diffusing capacity of carbon monoxide (DLCO)
Diffusing capacity of carbon monoxide (DLCO) in selected exercise intensities, lower-body pressures, and body positions. DLCO is measured using the single-breath dual gas pulmonary diffusing capacity for nitric oxide and carbon monoxide technique.
Measured: Time Frame: Days 2 and 3. Measurements will be taken during each stage of intervention, after a minimum of 2 minutes from the onset of each stage.
Capillary blood volume (Vc)
Capillary blood volume is a component of DLCO and is measured with the single-breath dual gas pulmonary diffusing capacity for nitric oxide and carbon monoxide technique.
Measured: Time Frame: Days 2 and 3. Measurements will be taken during each stage of intervention, after a minimum of 2 minutes from the onset of each stage.
Membrane diffusing capacity (Dm)
Membrane diffusing capacity is a component of DLCO and is measured with the single-breath dual gas pulmonary diffusing capacity for nitric oxide and carbon monoxide technique.
Measured: Time Frame: Days 2 and 3. Measurements will be taken during each stage of intervention, after a minimum of 2 minutes from the onset of each stage.
Secondary outcomes (6)
Exercise capacity
Exercise capacity (VO2peak) will be measured using an incremental exercise test.
Measured: Average peak VO2 recorded during the final 30seconds of the highest workload.
Physical activity - Step Count
Physical activity (number of steps per day) will be measured using an activity monitor.
Measured: Measured for 7 days after visit 1
Physical activity - Moderate to Vigorous
Number of minutes spent doing moderate to vigorous physical activity will be measured using an activity monitor.
Measured: Measured for 7 days after visit 1
Cardiac structure and function
Right ventricular systolic pressure during each intervention.
Measured: Time Frame: Day 4. Measurements will be taken during each stage of intervention, after a minimum of 2 minutes from the onset of each stage.
Blood volume
Total blood volume estimated using the carbon monoxide rebreathe method.
Measured: Time Frame: Visit 5. Measurement will be taken through study completion, an average of 10 minutes after the intervention.
Pulmonary vascular volumes
Chest computed tomorgraphy (CT) scan
Measured: Time Frame: Visit 6. Measurement will be taken through study completion, an average of 30 minutes per scan.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Electronic Cigarette UseStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Michael K Stickland, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07924007
- Sponsor's protocol ID
- Pro00165394
- Status last verified
- Nov 2026
- First submitted
- 6 Oct 2026
- Last updated
- 9 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD sharing plan.
Publications
Tedjasaputra V, van Diepen S, Phillips DB, Wong EYL, Bhutani M, Michaelchuk WW, Bryan TL, Stickland MK. Pulmonary capillary blood volume response to exercise is diminished in mild chronic obstructive pulmonary disease. Respir Med. 2018 Dec;145:57-65. doi: 10.1016/j.rmed.2018.10.015. Epub 2018 Oct 19.
PubMed 30509717Stickland MK, Neder JA, Guenette JA, O'Donnell DE, Jensen D. Using Cardiopulmonary Exercise Testing to Understand Dyspnea and Exercise Intolerance in Respiratory Disease. Chest. 2022 Jun;161(6):1505-1516. doi: 10.1016/j.chest.2022.01.021. Epub 2022 Jan 19.
PubMed 35065052Kizhakke Puliyakote AS, Elliott AR, Sa RC, Anderson KM, Crotty Alexander LE, Hopkins SR. Vaping disrupts ventilation-perfusion matching in asymptomatic users. J Appl Physiol (1985). 2021 Feb 1;130(2):308-317. doi: 10.1152/japplphysiol.00709.2020. Epub 2020 Nov 12.
PubMed 33180648Simovic T, Matheson C, Cobb K, Heefner A, Thode C, Colon M, Tunon E, Billingsley H, Salmons H, Ahmed SI, Carbone S, Garten R, Breland A, Cobb CO, Nana-Sinkam P, Rodriguez-Miguelez P. Young users of electronic cigarettes exhibit reduced cardiorespiratory fitness. J Appl Physiol (1985). 2024 Sep 1;137(3):569-580. doi: 10.1152/japplphysiol.00292.2024. Epub 2024 Jul 11.
PubMed 38990977Williams TG, Collins SE, Brotto AR, D'Souza AW, Ehnes CM, Hicks B, Weatherald J, Leung JM, Stickland MK. Do Young Individuals With Chronic E-Cigarette Exposure Display Cardiopulmonary Abnormalities During Exercise and Blunted Recruitment of Pulmonary Diffusing Capacity? Chest. 2026 Jun;169(6):1616-1627. doi: 10.1016/j.chest.2025.12.024. Epub 2026 Jan 2.
PubMed 41485699
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiopulmonary Complications of Electronic Cigarettes
- ClinicalTrials.gov ID
- NCT07924007
- Acronym / sponsor ID
- Pro00165394
- Conditions
- Electronic Cigarette Use, Cannabis Use
- Keywords
- Pulmonary vascular, Exercise capacity, Vape, Vaping, E-cigarette, Electronic cigarette, Cannabis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 9 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to look at whether changes in the blood vessels of the lungs are related to how well electronic cigarette users tolerate exercise. It also aims to investigate whether increasing blood flow to the lungs can improve the reduced ability of E-CIG users' lungs to transfer oxygen into the bloodstream.
Detailed description
Background:
The invention of electronic cigarettes (E-CIGs) in 2003 upended the trajectory of a decades-long public health campaign against cigarette smoking. Promoted as a safer method of inhaling nicotine compared to cigarettes and as smoking cessation tools, E-CIGs have substantially grown in popularity with rates of uptake now exceeding those of cigarette smoking. Surveys estimate that 5.8% of Canadians 15 years and older have used E-CIGs in the last 30 days. Young Canadians appear particularly susceptible: 13.6% of youths aged 15-19 and 19.7% aged 20-24 report past 30 day E-CIG use. Despite this rapid growth, questions remain as to their long-term safety. In 2019, an outbreak in the United States of acute lung injury related to E-CIGs (later termed E-cigarette or Vaping Use-Associated Lung Injury or EVALI) served as a warning that these devices were not benign. As Canadians increasingly reach for E-CIGs, especially at younger ages and not just for the purposes of smoking cessation, greater clarity into the pulmonary toxicities of E-CIG use is urgently needed.
E-CIG use has been linked to cardiopulmonary risks with potential long-term consequences for health. Even mild reductions in cardiopulmonary function during young adulthood are associated with increased risk of disease, morbidity, and all-cause mortality, underscoring the importance of protecting cardiopulmonary health. Recent work has shown that E-CIG use is associated with reduced exercise capacity (V̇O2peak), increased exertional dyspnea and greater ventilatory inefficiency. Additionally, emerging evidence linking E-CIG use with greater ventilation/perfusion heterogeneity and blunted pulmonary diffusing capacity for carbon monoxide (DLCO) recruitment during a volume-loading challenge suggests the presence of pulmonary vascular dysfunction. However, the mechanisms behind these findings remain largely unknown.
DLCO is a pivotal component of gas exchange and acid-base balance. Indeed, increases in lung diffusing capacity are critical to meeting the elevated metabolic demands during exercise and subsequently preventing a diffusion limitation, excessive increases in alveolar-arterial oxygen difference and possibly exercise induced arterial hypoxemia. Furthermore, reduced DLCO in those with respiratory diseases, such as chronic obstructive pulmonary disease, contributes to exercise intolerance and arterial hypoxemia. Physiological stressors such as exercise and controlled alterations in central blood volume (CBV) provide a means of challenging the cardiopulmonary system to reveal early dysfunction. Exercise increases cardiac output and pulmonary blood flow, requiring proportional increases in DLCO secondary to its components pulmonary capillary blood volume (VC) and membrane diffusing capacity (DM) to maintain efficient gas exchange. Similarly, lower body positive and negative pressure (LBPP/LBNP) transiently manipulate CBV, enabling assessment of pulmonary vascular responsiveness under controlled loading conditions. Evaluating DLCO during these stressors may therefore uncover abnormalities that are not detectable at rest, providing novel insight into the early pulmonary consequences of chronic E-CIG use. Additionally, as many individuals also consume cannabis, the investigators will also recruit a cannabis use only and a combined E-CIG and cannabis group.
Purposes/Objectives and Hypotheses:
The purpose of the current study is to:
- Describe the relationship between pulmonary vascular structural and functional parameters with exercise tolerance in E-CIG users, and
- Examine if blunted resting DLCO recruitment in E-CIG users can be normalized by increasing pulmonary blood volume through LBPP.
The investigators hypothesize that:
- E-CIG users will show a blunted DLCO response to exercise, particularly in females, and that impaired pulmonary vascular structure/function is associated with exercise intolerance in E-CIG users, and
- Increasing central blood volume via LBPP will normalize resting DLCO in E-CIG users.
Participant Selection:
The study design includes a cohort of individuals aged 12-40 years who have consented to be contacted from previous studies.
Inclusion criteria for the adolescent and adult cohorts are as follows:
Adolescent Cohort:
- Participants aged ≥12 and <18 years
- Control group: < 100 lifetime cigarettes, < 200 lifetime E-CIG puffs, and no cannabis exposure
- E-CIG Use Only: currently using E-CIGs every day or some days
- Cannabis Use: cannabis smoking history of > 1 joint-year
- Combined E-CIG and Cannabis Use: adolescents who meet both #3 and #4
Adult Cohort:
- Participants aged 18-40 years
- Control group: < 100 lifetime cigarettes, < 200 lifetime E-CIG puffs, and no cannabis exposure
- E-CIG Use Only: currently using E-CIGs every day or some days
- Cannabis Use: cannabis smoking history of > 1 joint-year
- Combined E-CIG and Cannabis Use: adults who meet both #3 and #4
Research Method/Procedures:
All visits will happen on separate days with at least 24 hours between visits.
Visit 1: Screening:
The participant will undergo a venous blood draw to measure cotinine and THC, and complete detailed questionnaires regarding demographic, medical, E-CIG and other substance use. The investigators will then perform pulmonary function tests on each participant. Finally, the participant will complete a graded exercise test (V̇O2max, expired gas analyses, operating lung volumes) on an upright cycle ergometer to volitional exhaustion with measurement of heart rate and blood pressure. Evaluation of dyspnea including intensity and unpleasantness will be performed at each workload. Further, reasons for test termination, dyspnea, and qualitative descriptors of dyspnea will be evaluated at peak exercise. Hemoglobin (Hb) concentration will be measured via finger prick prior to and following completion of exercise testing.
At the end of the visit, participants will be provided with an activity monitor to quantify physical activity. They will be instructed to wear the device 24-hours per day for seven consecutive days and return it to the research coordinator at the end of the monitoring period.
Fitbit wear compliance will be monitored by reviewing the recorded activity data and wear time following the 7-day monitoring period. The Fitbit data allows for clear differentiation of when the device is not worn. Participants will be instructed to wear the Fitbit for the duration of the monitoring period, except when removal is necessary (e.g., charging, water-related activities, contact sports). Brief periods of non-wear will be permitted, and participants will be instructed to put the device back on as soon as possible. The research team will review the data for periods of non-wear or missing data and will assess data completeness and integrity prior to analysis.
Visit 2: DLCO with Rest and Exercise:
Exercise will be used as a physiological stressor to increase central blood volume. The participant will perform DLCO maneuvers at rest and during exercise at varying exercise intensities between ~20%-100% of their V̇O2max. Participants will also be equipped with a continuous blood pressure monitor, a brachial blood pressure cuff, an electrocardiogram, and a thoracic impedance device. At each stage participants will also breathe on a mouthpiece for two minutes to collect metabolic data: ventilation (V̇E), oxygen consumption (V̇O2), and carbon dioxide production (V̇CO2). Cardiovascular parameters (blood pressure, peripheral venous pressure, heart rate, thoracic impedance) will be measured continuously. Hb via finger prick will also be measured at each intensity.
As per recommendations , participants will perform standard DLCO breath-hold maneuvers for 6 seconds, and maneuvers will be performed twice at each intensity. A washout period of at least 4 minutes at rest and 2 minutes between each breath hold during exercise will be completed to ensure adequate recovery and blood gas equilibration. Participants will not complete more than 15 DLCO breath holds during each experimental visit.
Visit 3: Central Blood Volume Manipulation and DLCO:
The participant will perform the DLCO test at various levels of LBNP/LBPP ranging from -80 mmHg to +40 mmHg. Changes in central blood volume during LBNP are equivalent to standing upright (-80 mmHg LBNP), and changes in central blood volume during LBPP are equivalent to lying down with the participant's feet above their head (+40 mmHg LBPP). For the LBNP/LBPP trials, participants will lie supine with their lower body (from the iliac crest to their toes) inside the pressure chamber. The participant's lower body will be sealed within the differential pressure chamber using a neoprene skirt to prevent any air leakage from the insides of the chamber. Negative and positive pressures are induced by a vacuum pump that either reduces or increases atmospheric pressure inside the chamber in a controlled and precise manner. The vacuum pump is controlled by a trained member of the research team, and chamber pressure is continuously monitored via a digital manometer.
Participants will be equipped with a continuous blood pressure monitor, a brachial blood pressure cuff, an electrocardiogram, and a thoracic impedance device. Each stage of LBPP/LBNP will begin with two minutes of stabilization followed by two DLCO breath-hold maneuvers. At each stage, participants will also breathe on a mouthpiece for two minutes to collect metabolic data, and oscillometry measurements will be completed twice per stage. Cardiovascular parameters will be measured continuously. Hb via finger prick will be measured prior to the first pressure stage and again at the transition between LBNP and LBPP conditions.
Participants will not complete more than 15 breath holds during the experimental visit. As per recommendations, participants will perform standard DLCO breath-hold maneuvers for 6 seconds, and maneuvers will be performed twice at each stage. A washout period of at least 4 minutes between each breath hold will be completed to ensure adequate recovery and blood gas equilibration.
Visit 4: Ultrasound with Exercise and LBPP/LBNP:
Participants will complete the same interventions as visit 3 (exercise at ~20%-100% of their V̇O2max) and visit 4 (LBNP/LBPP -80 to +40 mmHg). At each stage of exercise and LBNP/LBPP, a trained sonographer will obtain images of the heart via echocardiography.
Visit 5: Blood Volume Measurement Participants from the adult cohort only will undergo a carbon monoxide rebreathe protocol to estimate blood volume. A certified technician will insert an IV catheter into an antecubital vein to collect serial blood samples. While lying supine, participants will inhale a bolus of carbon monoxide (0.7-1.0 mL/kg bodyweight) mixed with 100% oxygen on a rebreathing circuit for two minutes and will then continue to rest for eight additional minutes. Venous blood samples measuring carboxyhemoglobin before the rebreathe and at eight and 10 minutes after the rebreathe will allow the calculation of blood volume.
Visit 6: Computed Tomography:
Participants from the adult cohort only will report to a Medical Imaging Centre for the CT scan. Following a briefing by the Medical Imaging Centre staff, participants will lie supine on the CT scanner and the region of interest in the chest will be obtained. The participant will remain as still as possible and inhale to total lung capacity and hold their breath. During the breath hold, images will be acquired. The participant will then empty their lungs as far as they can and imaging will be repeated.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adult Participants | Experimental | Other: Lower body positive and negative pressure, Other: ExerciseAdult participants will complete all six visits as outlined in the study description. |
| Adolescent Participants | Experimental | Other: Lower body positive and negative pressure, Other: ExerciseAdolescent participants will complete visits 1-4 as outlined in the study description. |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- Participants aged ≥12 and <18 years
- Non-smoking and Non-E-CIG Use: <100 lifetime cigarettes and < 200 E-CIG puffs
- E-CIG Use Only: currently using E-CIGs every day or some days
- Cannabis Use: cannabis smoking history of > 1 joint-year
- Combined E-CIG and Cannabis Use: adolescents who meet both #3 and #4
Key exclusion criteria (7 listed)
- Contraindication to pulmonary function testing (i.e. recent thoracic or abdominal surgery, aneurysms, cardiovascular instability)
- Unable to provide informed consent
- Currently undergoing treatment for lung cancer
- Cigarette smoking in the past 6 months
- Physician-diagnosed chronic lung disease (e.g. cystic fibrosis, asthma, primary ciliary dyskinesia, bronchopulmonary dysplasia) (adolescent arm only)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lower body positive and negative pressurePrimary outcomes will be assessed during graded lower body positive pressure (+10, +20, +30 mmHg) and negative pressure (-15, -30, -45, -60 mmHg). | Other | Adolescent Participants, Adult Participants |
| ExercisePrimary outcomes will be examined at rest and at exercise intensities between ~20%-100% of their V̇O2max. | Other | Adolescent Participants, Adult Participants |
Primary outcome
Diffusing capacity of carbon monoxide (DLCO)
Time frame: Time Frame: Days 2 and 3. Measurements will be taken during each stage of intervention, after a minimum of 2 minutes from the onset of each stage.
Diffusing capacity of carbon monoxide (DLCO) in selected exercise intensities, lower-body pressures, and body positions. DLCO is measured using the single-breath dual gas pulmonary diffusing capacity for nitric oxide and carbon monoxide technique.
Capillary blood volume (Vc)
Time frame: Time Frame: Days 2 and 3. Measurements will be taken during each stage of intervention, after a minimum of 2 minutes from the onset of each stage.
Capillary blood volume is a component of DLCO and is measured with the single-breath dual gas pulmonary diffusing capacity for nitric oxide and carbon monoxide technique.
Membrane diffusing capacity (Dm)
Time frame: Time Frame: Days 2 and 3. Measurements will be taken during each stage of intervention, after a minimum of 2 minutes from the onset of each stage.
Membrane diffusing capacity is a component of DLCO and is measured with the single-breath dual gas pulmonary diffusing capacity for nitric oxide and carbon monoxide technique.
6 secondary outcomes
Exercise capacity
Time frame: Average peak VO2 recorded during the final 30seconds of the highest workload.
Physical activity - Step Count
Time frame: Measured for 7 days after visit 1
Physical activity - Moderate to Vigorous
Time frame: Measured for 7 days after visit 1
Cardiac structure and function
Time frame: Time Frame: Day 4. Measurements will be taken during each stage of intervention, after a minimum of 2 minutes from the onset of each stage.
Blood volume
Time frame: Time Frame: Visit 5. Measurement will be taken through study completion, an average of 10 minutes after the intervention.
Pulmonary vascular volumes
Time frame: Time Frame: Visit 6. Measurement will be taken through study completion, an average of 30 minutes per scan.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2026.
- Background: PubMed 30509717Tedjasaputra V, van Diepen S, Phillips DB, Wong EYL, Bhutani M, Michaelchuk WW, Bryan TL, Stickland MK. Pulmonary capillary blood volume response to exercise is diminished in mild chronic obstructive pulmonary disease. Respir Med. 2018 Dec;145:57-65. doi: 10.1016/j.rmed.2018.10.015. Epub 2018 Oct 19.
- Background: PubMed 35065052Stickland MK, Neder JA, Guenette JA, O'Donnell DE, Jensen D. Using Cardiopulmonary Exercise Testing to Understand Dyspnea and Exercise Intolerance in Respiratory Disease. Chest. 2022 Jun;161(6):1505-1516. doi: 10.1016/j.chest.2022.01.021. Epub 2022 Jan 19.
- Background: PubMed 33180648Kizhakke Puliyakote AS, Elliott AR, Sa RC, Anderson KM, Crotty Alexander LE, Hopkins SR. Vaping disrupts ventilation-perfusion matching in asymptomatic users. J Appl Physiol (1985). 2021 Feb 1;130(2):308-317. doi: 10.1152/japplphysiol.00709.2020. Epub 2020 Nov 12.
- Background: PubMed 38990977Simovic T, Matheson C, Cobb K, Heefner A, Thode C, Colon M, Tunon E, Billingsley H, Salmons H, Ahmed SI, Carbone S, Garten R, Breland A, Cobb CO, Nana-Sinkam P, Rodriguez-Miguelez P. Young users of electronic cigarettes exhibit reduced cardiorespiratory fitness. J Appl Physiol (1985). 2024 Sep 1;137(3):569-580. doi: 10.1152/japplphysiol.00292.2024. Epub 2024 Jul 11.
- Background: PubMed 41485699Williams TG, Collins SE, Brotto AR, D'Souza AW, Ehnes CM, Hicks B, Weatherald J, Leung JM, Stickland MK. Do Young Individuals With Chronic E-Cigarette Exposure Display Cardiopulmonary Abnormalities During Exercise and Blunted Recruitment of Pulmonary Diffusing Capacity? Chest. 2026 Jun;169(6):1616-1627. doi: 10.1016/j.chest.2025.12.024. Epub 2026 Jan 2.
- Individual participant dataSharing planned: No. No IPD sharing plan.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael K Stickland, PhD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lower body positive and negative pressure and Exercise in people with Electronic Cigarette Use and Cannabis Use, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Desi P Fuhr, MSc (7804921121, fuhr@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diffusing capacity of carbon monoxide (DLCO) (time frame: Time Frame: Days 2 and 3. Measurements will be taken during each stage of intervention, after a minimum of 2 minutes from the onset of each stage.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07924007, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2026.