- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06335329
Point-of-Care Ultrasound (POCUS) Findings and Impact on Vaping
Point-of-Care Ultrasound Findings and Impact on Vaping Behaviors in Adolescents
Vaping has emerged as a prominent public health crisis in recent years. In 2023, the National Youth Tobacco Survey found that more than 2.1 million adolescents endorse vaping, with 25% of those endorsing daily use. Many adolescents also perceive vapes as safer than cigarettes, and more acceptable to use both indoors and outdoors compared to cigarettes. Vapes are available in numerous device and delivery systems, with the psychoactive agent commonly including nicotine or cannabis, although these can be of a wide variety of concentrations and formulations. They may be ultra-compact and allow for ease of concealment. In addition, they are produced in a variety of appealing flavorings such as candy, desserts, and fruits. Other constituents include the liquids and aerosolized components of the vaping cartridges, including formaldehyde, acetone, glycerol, propylene glycol, acetaldehyde, and heavy metals. Many of the flavoring concentrates, as well as the vaporized solvents, have not been evaluated for long term safety. One of these additives, vitamin E acetate, present in primarily illicit vaping devices, rose to national attention in 2019 for a suspected link to the dramatic increase in vaping/e-cigarette associated lung injury (EVALI) cases, with over 60 confirmed deaths since that time.
To our knowledge, there are no studies evaluating the lung ultrasound findings of asymptomatic vapers. However, there is data to suggest that vaping can lead to pulmonary toxicity in in-vitro and animal models, including increased inflammatory cytokines, hyperreactivity, and oxidative stress. In addition, studies found the risk of bronchitic symptoms is twice as likely in current adolescent vapers, compared to those who have never vaped before. Given the potential pulmonary toxicity of vaping, as well as the increased percentage of adolescent vaping activity in recent years, investigators aim to evaluate baseline lung ultrasound findings in adolescents who vape. Concurrently, investigators will assess if observing their lung ultrasound findings can alter their attitudes and behaviors towards vaping. Prior adult studies have found that showing patients' their atherosclerosis plaque increased the motivation to quit and cessation rates. Additionally, data in pregnant patients found real-time ultrasound feedback of smoking effects on the fetus lead to near abstinence in light smokers. Given the frequent use of point-of-care ultrasound in the emergency department, investigators hope to assess an innovative intervention for cessation.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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South Carolina
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Charleston, South Carolina, United States, 29412
- Medical University of South Carolina
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Ages 12-18 years of age
- Has own individual cell phone or email for communication
- Member of a vaping history group that is not yet full for enrollment (ex: up to 100 vapers, up to 100 non-vapers)
- Able to speak and understand English
Exclusion Criteria:
- Chronic Lung Disease
- History of pneumothorax
- Prior thoracic surgery including VATS (Video-assisted thoracoscopic surgery)
- Sickle cell disease
- Current or prior cancer
- Significant congenital heart disease
- Acute upper respiratory infection (cough or congestion in the last 3 days)
- Acute chest trauma
- Acute pulmonary embolism
- Sedation medication administered prior to study image acquisition
- Known allergy or sensitivity to ultrasound gel
- Significant acute psychosis, mania, or suicidal ideation
- Any other medical or psychiatric condition or other significant concern that in the investigator's opinion would impact participant safety or compliance with study instructions, or potentially confound the interpretation of findings
- Inability or unwillingness of subject or legal guardian/representative to give informed consent/assent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: standard vaping cessation counseling (SOC) + ultrasound (US)
Participants will receive SOC via a publicly available infographic from the Food and Drug Administration).
They will also be provided with a discussion of lung US findings
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The investigator will obtain point-of-care ultrasound images to assess the lung findings in 12 lung fields. These 12 lung fields will include the standard protocol of the upper and lower halves of the anterior, lateral, and posterior chest bilaterally. Subjects' ultrasound images will be scored using a modified lung ultrasound score (LUS). Each of the 12 lung fields will be scored from 0-5, with a total score of 0-60 (noted below). The participants will watch their ultrasound being performed, looking at their lungs in real time. Then, the ultrasound findings will be discussed with the participant. Modified LUS 0: No B-lines present
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No Intervention: Standard vaping cessation counseling (SOC) alone
Participants will receive a SOC alone.
They will be kept blinded to their lung point-of-care ultrasound findings and will not be able to visualize the images as the ultrasound is performed.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Lung Ultrasound Findings
Time Frame: Day 1
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The purpose of this study is to establish the lung findings in vaping adolescents, specifically point-of-care ultrasound scores, and to identify factors such as age, sex, race, and vital signs, that contribute to variability in lung findings. Each of the 12 lung fields will be scored from 0-5, with a total score of 0-60. The modified LUS is defined below. Modified LUS 0: No B-lines present
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Day 1
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Behavioral Changes
Time Frame: Day 1, at 2 weeks, at 2 months
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Questionnaire to assess if observing lung findings can alter adolescents' vaping behaviors, risk perception, behavioral intent, and motivation to quit.
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Day 1, at 2 weeks, at 2 months
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Collaborators and Investigators
Publications and helpful links
General Publications
- Gorukanti A, Delucchi K, Ling P, Fisher-Travis R, Halpern-Felsher B. Adolescents' attitudes towards e-cigarette ingredients, safety, addictive properties, social norms, and regulation. Prev Med. 2017 Jan;94:65-71. doi: 10.1016/j.ypmed.2016.10.019. Epub 2016 Oct 20.
- Overbeek DL, Kass AP, Chiel LE, Boyer EW, Casey AMH. A review of toxic effects of electronic cigarettes/vaping in adolescents and young adults. Crit Rev Toxicol. 2020 Jul;50(6):531-538. doi: 10.1080/10408444.2020.1794443. Epub 2020 Jul 27.
- Fadus MC, Smith TT, Squeglia LM. The rise of e-cigarettes, pod mod devices, and JUUL among youth: Factors influencing use, health implications, and downstream effects. Drug Alcohol Depend. 2019 Aug 1;201:85-93. doi: 10.1016/j.drugalcdep.2019.04.011. Epub 2019 May 23.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Pro00133616
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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