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Cardiopulmonary Complications of Electronic Cigarettes

2026年11月4日 更新者:University of Alberta

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.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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:

  1. Describe the relationship between pulmonary vascular structural and functional parameters with exercise tolerance in E-CIG users, and
  2. Examine if blunted resting DLCO recruitment in E-CIG users can be normalized by increasing pulmonary blood volume through LBPP.

The investigators hypothesize that:

  1. 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
  2. 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:

  1. Participants aged ≥12 and <18 years
  2. Control group: < 100 lifetime cigarettes, < 200 lifetime E-CIG puffs, and no cannabis exposure
  3. E-CIG Use Only: currently using E-CIGs every day or some days
  4. Cannabis Use: cannabis smoking history of > 1 joint-year
  5. Combined E-CIG and Cannabis Use: adolescents who meet both #3 and #4

Adult Cohort:

  1. Participants aged 18-40 years
  2. Control group: < 100 lifetime cigarettes, < 200 lifetime E-CIG puffs, and no cannabis exposure
  3. E-CIG Use Only: currently using E-CIGs every day or some days
  4. Cannabis Use: cannabis smoking history of > 1 joint-year
  5. 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.

研究の種類

介入

入学 (推定)

480

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前:Desi P Fuhr, MSc
  • 電話番号:7804921121
  • メール:fuhr@ualberta.ca

研究場所

    • Alberta
      • Edmonton、Alberta、カナダ、T6G2R3
        • Clinical Physiology Laboratory
        • コンタクト:
        • コンタクト:

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

12年~40年 (子、大人)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

Inclusion Criteria:

Adolescent Cohort:

  1. Participants aged ≥12 and <18 years
  2. Non-smoking and Non-E-CIG Use: <100 lifetime cigarettes and < 200 E-CIG puffs
  3. E-CIG Use Only: currently using E-CIGs every day or some days
  4. Cannabis Use: cannabis smoking history of > 1 joint-year
  5. Combined E-CIG and Cannabis Use: adolescents who meet both #3 and #4

Adult Cohort:

  1. Participants aged 18-40 years
  2. Non-smoking and Non-E-CIG Use: <100 lifetime cigarettes and < 200 E-CIG puffs
  3. E-CIG Use Only: currently using E-CIGs every day or some days
  4. Cannabis Use: cannabis smoking history of > 1 joint-year
  5. Combined E-CIG and Cannabis Use: adults who meet both #3 and #4

Exclusion Criteria:

  1. Contraindication to pulmonary function testing (i.e. recent thoracic or abdominal surgery, aneurysms, cardiovascular instability)
  2. Unable to provide informed consent
  3. Currently undergoing treatment for lung cancer
  4. Cigarette smoking in the past 6 months
  5. Physician-diagnosed chronic lung disease (e.g. cystic fibrosis, asthma, primary ciliary dyskinesia, bronchopulmonary dysplasia) (adolescent arm only)
  6. 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.
  7. 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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:基礎科学
  • 割り当て:非ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的:Adult Participants

Adult participants will complete all six visits as outlined in the study description.

Primary outcomes will be assessed during graded lower body positive pressure (+10, +20, +30 mmHg) and negative pressure (-15, -30, -45, -60 mmHg).

Primary outcomes will be examined at rest and at exercise intensities between ~20%-100% of their V̇O2max.

実験的:Adolescent Participants

Adolescent participants will complete visits 1-4 as outlined in the study description.

Primary outcomes will be assessed during graded lower body positive pressure (+10, +20, +30 mmHg) and negative pressure (-15, -30, -45, -60 mmHg).

Primary outcomes will be examined at rest and at exercise intensities between ~20%-100% of their V̇O2max.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Diffusing capacity of carbon monoxide (DLCO)
時間枠: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.

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)
時間枠: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.

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)
時間枠: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.

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.

二次結果の測定

結果測定
メジャーの説明
時間枠
Exercise capacity
時間枠:Average peak VO2 recorded during the final 30seconds of the highest workload.

Exercise capacity (VO2peak) will be measured using an incremental exercise test.

Average peak VO2 recorded during the final 30seconds of the highest workload.
Physical activity - Step Count
時間枠:Measured for 7 days after visit 1

Physical activity (number of steps per day) will be measured using an activity monitor.

Measured for 7 days after visit 1
Physical activity - Moderate to Vigorous
時間枠:Measured for 7 days after visit 1

Number of minutes spent doing moderate to vigorous physical activity will be measured using an activity monitor.

Measured for 7 days after visit 1
Cardiac structure and function
時間枠: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.

Right ventricular systolic pressure during each intervention.

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
時間枠:Time Frame: Visit 5. Measurement will be taken through study completion, an average of 10 minutes after the intervention.

Total blood volume estimated using the carbon monoxide rebreathe method.

Time Frame: Visit 5. Measurement will be taken through study completion, an average of 10 minutes after the intervention.
Pulmonary vascular volumes
時間枠:Time Frame: Visit 6. Measurement will be taken through study completion, an average of 30 minutes per scan.

Chest computed tomorgraphy (CT) scan

Time Frame: Visit 6. Measurement will be taken through study completion, an average of 30 minutes per scan.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

協力者

捜査官

  • 主任研究者:Michael K Stickland, PhD、University of Alberta

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年11月1日

一次修了 (推定)

2028年1月1日

研究の完了 (推定)

2028年12月30日

試験登録日

最初に提出

2026年10月6日

QC基準を満たした最初の提出物

2026年11月4日

最初の投稿 (実際)

2026年11月9日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月9日

QC基準を満たした最後の更新が送信されました

2026年11月4日

最終確認日

2026年11月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • Pro00165394

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

No IPD sharing plan.

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。