The Canadian Lung Outcomes in Users of Vaping Devices (CLOUD) Study: protocol for a prospective, observational cohort study
Introduction The rapid growth in popularity of e-cigarettes over the past decade has prompted concerns about their impact on long-term respiratory health. Small airway injury is suspected to be a direct consequence of e-cigarette use and may be quantifiable by novel structural and functional diagnos...
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2025-03-01
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| author | Michael K Stickland Stephen Lam Hasina Samji Sarah Svenningsen Rachel L Eddy Don D Sin Rafael Meza Xuan Li Jonathon Leipsic Ana I Hernandez Cordero Julia Yang Theo J Moraes Joanna MacLean Shawn Aaron Jonathan H Rayment Simon Couillard Terence Ho Clarus Leung Laura L Struik Heather Drew Paloma Burns Satvir S Dhillon Jordan Guenette Trisha Tulloch Tina Afshar Brandon Zanette Giles Santyr François-Pierre Counil Sheila Matano Giulia de Arruda Maluf Carmen Feng Lydia Bal Harnoor Dhaliwal Adeola Mumuni Caitlyn Lui Janice M Leung |
| author_facet | Michael K Stickland Stephen Lam Hasina Samji Sarah Svenningsen Rachel L Eddy Don D Sin Rafael Meza Xuan Li Jonathon Leipsic Ana I Hernandez Cordero Julia Yang Theo J Moraes Joanna MacLean Shawn Aaron Jonathan H Rayment Simon Couillard Terence Ho Clarus Leung Laura L Struik Heather Drew Paloma Burns Satvir S Dhillon Jordan Guenette Trisha Tulloch Tina Afshar Brandon Zanette Giles Santyr François-Pierre Counil Sheila Matano Giulia de Arruda Maluf Carmen Feng Lydia Bal Harnoor Dhaliwal Adeola Mumuni Caitlyn Lui Janice M Leung |
| author_sort | Michael K Stickland |
| collection | DOAJ |
| description | Introduction The rapid growth in popularity of e-cigarettes over the past decade has prompted concerns about their impact on long-term respiratory health. Small airway injury is suspected to be a direct consequence of e-cigarette use and may be quantifiable by novel structural and functional diagnostic modalities.Methods and analysis In a multicentre observational longitudinal study, participants will be enrolled in either an adolescent (ages ≥12 and <19 years) or an adult arm (≥19 years old) and followed over 3 years across three time points (baseline, 18 months and 36 months). In the adolescent arm, a total of 50 e-cigarette and 50 non-e-cigarette users will be enrolled across 4 sites. In the adult arm, a total of 100 e-cigarette users, 100 non-e-cigarette users, and an additional 100 combustible cigarette-only users and 100 dual combustible cigarette-e-cigarette users will be enrolled across 5 sites. Participants will undergo respiratory questionnaires, pulmonary function tests, oscillometry, cardiopulmonary exercise testing, hyperpolarised 129-xenon gas MRI and blood collection. In adolescent participants only, multiple breath washout and induced sputum collection will be performed. Adult participants will also undergo inspiratory/expiratory chest CT and bronchoscopy. The primary endpoint will be a composite of small airway dysfunction according to oscillometry, cardiopulmonary testing and/or chest imaging parameters.Ethics and dissemination This protocol has been approved by The University of British Columbia-Providence Health Care Research Ethics Board (Certificate H24-00374). The use of hyperpolarised 129-xenon gas in this study has been approved by Health Canada (Certificate HC6-024-c291776). Written documentation of informed consent will be required prior to study initiation. We will seek to enrol adolescent participants who are capable of providing informed consent with an optional support statement from a parent encouraged but not required. Study findings will be disseminated to medical/scientific audiences through scientific conferences and published manuscripts respecting the Strengthening the Reporting of Observational Studies in Epidemiology statement, to youths through outreach events at high schools and community programmes and through social media, and to adults through lung health community events.Trial registration number NCT06819969. |
| format | Article |
| id | doaj-art-0bccd4e5ccae4651a565baa387b119b0 |
| institution | DOAJ |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-03-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-0bccd4e5ccae4651a565baa387b119b02025-08-20T02:46:50ZengBMJ Publishing GroupBMJ Open2044-60552025-03-0115310.1136/bmjopen-2025-100568The Canadian Lung Outcomes in Users of Vaping Devices (CLOUD) Study: protocol for a prospective, observational cohort studyMichael K Stickland0Stephen Lam1Hasina Samji2Sarah Svenningsen3Rachel L Eddy4Don D Sin5Rafael Meza6Xuan Li7Jonathon Leipsic8Ana I Hernandez Cordero9Julia Yang10Theo J Moraes11Joanna MacLean12Shawn Aaron13Jonathan H Rayment14Simon Couillard15Terence Ho16Clarus Leung17Laura L Struik18Heather Drew19Paloma Burns20Satvir S Dhillon21Jordan Guenette22Trisha Tulloch23Tina Afshar24Brandon Zanette25Giles Santyr26François-Pierre Counil27Sheila Matano28Giulia de Arruda Maluf29Carmen Feng30Lydia Bal31Harnoor Dhaliwal32Adeola Mumuni33Caitlyn Lui34Janice M Leung355 Division of Pulmonary Medicine, Department of Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada13 Division of Respiratory Medicine, Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada9 Faculty of Health Sciences, Simon Fraser University, Burnaby, British Columbia, Canada; Prevention and Health Promotion Division, British Columbia Centre for Disease Control, Vancouver, British Columbia, Canada7 Firestone Institute for Respiratory Health, St. Joseph’s Healthcare Hamilton; Department of Medicine, McMaster University, Hamilton, Ontario, Canada1 Centre for Heart Lung Innovation, The University of British Columbia, Vancouver, British Columbia, Canada1 Centre for Heart Lung Innovation, The University of British Columbia, Vancouver, British Columbia, Canada10 British Columbia Cancer Research Institute, Department of Integrative Oncology, Vancouver, British Columbia, Canada1 Centre for Heart Lung Innovation, The University of British Columbia, Vancouver, British Columbia, Canada2 Department of Radiology, University of British Columbia, Vancouver, British Columbia, Canada1 Centre for Heart Lung Innovation, The University of British Columbia, Vancouver, British Columbia, Canada1 Centre for Heart Lung Innovation, The University of British Columbia, Vancouver, British Columbia, Canada15 Division of Respiratory Medicine, The Hospital for Sick Children, Toronto, Ontario, Canada14 Division of Respiratory Medicine, Department of Pediatrics, Faculty of Medicine, University of Alberta, Edmonton, Alberta, Canada12 The Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada3 Division of Respiratory Medicine, Department of Pediatrics, British Columbia Children’s Hospital, University of British Columbia, Vancouver, BC, Canada4 Faculté de médecine et des sciences de la santé, Université de Sherbrooke, Sherbrooke, Québec, Canada7 Firestone Institute for Respiratory Health, St. Joseph’s Healthcare Hamilton; Department of Medicine, McMaster University, Hamilton, Ontario, Canada13 Division of Respiratory Medicine, Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada11 School of Nursing, University of British Columbia Okanagan, Kelowna, BC, Canada1 Centre for Heart Lung Innovation, The University of British Columbia, Vancouver, British Columbia, Canada1 Centre for Heart Lung Innovation, The University of British Columbia, Vancouver, British Columbia, Canada1 Centre for Heart Lung Innovation, The University of British Columbia, Vancouver, British Columbia, Canada1 Centre for Heart Lung Innovation, The University of British Columbia, Vancouver, British Columbia, Canada8 Division of Adolescent Medicine, Hospital for Sick Children; Centre for Addiction and Mental Health; Division of Mental Health and Addiction, Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada13 Division of Respiratory Medicine, Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada16 Translational Medicine Program, The Hospital for Sick Children, Toronto, Ontario, Canada17 Department of Medical Biophysics, University of Toronto, Toronto, Ontario, Canada18 Department of Pediatrics, Université de Sherbrooke, Sherbrooke, Québec, Canada19 BC Lung Foundation, Vancouver, British Columbia, Canada20 Capturing Health and Resilience Trajectories (CHART) Lab, Simon Fraser University Faculty of Health Sciences, Burnaby, British Columbia, Canada20 Capturing Health and Resilience Trajectories (CHART) Lab, Simon Fraser University Faculty of Health Sciences, Burnaby, British Columbia, Canada20 Capturing Health and Resilience Trajectories (CHART) Lab, Simon Fraser University Faculty of Health Sciences, Burnaby, British Columbia, Canada20 Capturing Health and Resilience Trajectories (CHART) Lab, Simon Fraser University Faculty of Health Sciences, Burnaby, British Columbia, Canada20 Capturing Health and Resilience Trajectories (CHART) Lab, Simon Fraser University Faculty of Health Sciences, Burnaby, British Columbia, Canada20 Capturing Health and Resilience Trajectories (CHART) Lab, Simon Fraser University Faculty of Health Sciences, Burnaby, British Columbia, Canada1 Centre for Heart Lung Innovation, The University of British Columbia, Vancouver, British Columbia, CanadaIntroduction The rapid growth in popularity of e-cigarettes over the past decade has prompted concerns about their impact on long-term respiratory health. Small airway injury is suspected to be a direct consequence of e-cigarette use and may be quantifiable by novel structural and functional diagnostic modalities.Methods and analysis In a multicentre observational longitudinal study, participants will be enrolled in either an adolescent (ages ≥12 and <19 years) or an adult arm (≥19 years old) and followed over 3 years across three time points (baseline, 18 months and 36 months). In the adolescent arm, a total of 50 e-cigarette and 50 non-e-cigarette users will be enrolled across 4 sites. In the adult arm, a total of 100 e-cigarette users, 100 non-e-cigarette users, and an additional 100 combustible cigarette-only users and 100 dual combustible cigarette-e-cigarette users will be enrolled across 5 sites. Participants will undergo respiratory questionnaires, pulmonary function tests, oscillometry, cardiopulmonary exercise testing, hyperpolarised 129-xenon gas MRI and blood collection. In adolescent participants only, multiple breath washout and induced sputum collection will be performed. Adult participants will also undergo inspiratory/expiratory chest CT and bronchoscopy. The primary endpoint will be a composite of small airway dysfunction according to oscillometry, cardiopulmonary testing and/or chest imaging parameters.Ethics and dissemination This protocol has been approved by The University of British Columbia-Providence Health Care Research Ethics Board (Certificate H24-00374). The use of hyperpolarised 129-xenon gas in this study has been approved by Health Canada (Certificate HC6-024-c291776). Written documentation of informed consent will be required prior to study initiation. We will seek to enrol adolescent participants who are capable of providing informed consent with an optional support statement from a parent encouraged but not required. Study findings will be disseminated to medical/scientific audiences through scientific conferences and published manuscripts respecting the Strengthening the Reporting of Observational Studies in Epidemiology statement, to youths through outreach events at high schools and community programmes and through social media, and to adults through lung health community events.Trial registration number NCT06819969.https://bmjopen.bmj.com/content/15/3/e100568.full |
| spellingShingle | Michael K Stickland Stephen Lam Hasina Samji Sarah Svenningsen Rachel L Eddy Don D Sin Rafael Meza Xuan Li Jonathon Leipsic Ana I Hernandez Cordero Julia Yang Theo J Moraes Joanna MacLean Shawn Aaron Jonathan H Rayment Simon Couillard Terence Ho Clarus Leung Laura L Struik Heather Drew Paloma Burns Satvir S Dhillon Jordan Guenette Trisha Tulloch Tina Afshar Brandon Zanette Giles Santyr François-Pierre Counil Sheila Matano Giulia de Arruda Maluf Carmen Feng Lydia Bal Harnoor Dhaliwal Adeola Mumuni Caitlyn Lui Janice M Leung The Canadian Lung Outcomes in Users of Vaping Devices (CLOUD) Study: protocol for a prospective, observational cohort study BMJ Open |
| title | The Canadian Lung Outcomes in Users of Vaping Devices (CLOUD) Study: protocol for a prospective, observational cohort study |
| title_full | The Canadian Lung Outcomes in Users of Vaping Devices (CLOUD) Study: protocol for a prospective, observational cohort study |
| title_fullStr | The Canadian Lung Outcomes in Users of Vaping Devices (CLOUD) Study: protocol for a prospective, observational cohort study |
| title_full_unstemmed | The Canadian Lung Outcomes in Users of Vaping Devices (CLOUD) Study: protocol for a prospective, observational cohort study |
| title_short | The Canadian Lung Outcomes in Users of Vaping Devices (CLOUD) Study: protocol for a prospective, observational cohort study |
| title_sort | canadian lung outcomes in users of vaping devices cloud study protocol for a prospective observational cohort study |
| url | https://bmjopen.bmj.com/content/15/3/e100568.full |
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