VapingNCT06335329
Point-of-Care Ultrasound (POCUS) Findings and Impact on Vaping
A study testing Discussion of point-of-care ultrasound lung findings in people with Vaping, run by Medical University of South Carolina at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaping
- What is being tested?
- Discussion of point-of-care ultrasound lung findings
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2024to 11 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29412
About this study
Official title: 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.
- Conditions
- Vaping
- Being tested
- Discussion of point-of-care ultrasound lung findings
- Keywords
- vaping, Point-of-care ultrasound, adolescents, POCUS
- Medical subject headings
- Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discussion of point-of-care ultrasound lung findingsBehavioural
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
- 1 well-defined B-line
- 2-3 well-defined B-lines
- >3 B-lines
- Confluent B-lines
- Lobar consolidation
- C: Noted if subpleural consolidation present
- E: Noted if pleural effusion present
| Study group | Role | What they receive |
|---|---|---|
| standard vaping cessation counseling (SOC) + ultrasound (US) | Active comparator | 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 Receives: Behavioral: Discussion of point-of-care ultrasound lung findings |
| Standard vaping cessation counseling (SOC) alone | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung Ultrasound Findings
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
- 1 well-defined B-line
- 2-3 well-defined B-lines
- >3 B-lines
- Confluent B-lines
- Lobar consolidation
- C: Noted if subpleural consolidation present
- E: Noted if pleural effusion present
Measured: Day 1
Behavioral Changes
Questionnaire to assess if observing lung findings can alter adolescents' vaping behaviors, risk perception, behavioral intent, and motivation to quit.
Measured: Day 1, at 2 weeks, at 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start17 Jul 2024
- Primary completion11 Feb 2026
- Study completion11 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for VapingStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06335329
- Sponsor's protocol ID
- Pro00133616
- Status last verified
- Feb 2026
- First submitted
- 14 Mar 2024
- Last updated
- 17 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 27773711Overbeek 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.
PubMed 32715837Fadus 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.
PubMed 31200279
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point-of-Care Ultrasound Findings and Impact on Vaping Behaviors in Adolescents
- ClinicalTrials.gov ID
- NCT06335329
- Acronym / sponsor ID
- Pro00133616
- Conditions
- Vaping
- Keywords
- vaping, Point-of-care ultrasound, adolescents, POCUS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 17 Jul 2024 (actual)
- Primary completion
- 11 Feb 2026 (actual)
- Study completion
- 11 Feb 2026 (actual)
- First posted
- 28 Mar 2024 (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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard vaping cessation counseling (SOC) + ultrasound (US) | Active comparator | Behavioral: Discussion of point-of-care ultrasound lung findingsParticipants 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 |
| Standard vaping cessation counseling (SOC) alone | No intervention | –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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- Chronic Lung Disease
- History of pneumothorax
- Prior thoracic surgery including VATS (Video-assisted thoracoscopic surgery)
- Sickle cell disease
- Current or prior cancer
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 |
|---|---|---|
| Discussion of point-of-care ultrasound lung findingsThe 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 1. 1 well-defined B-line 2. 2-3 well-defined B-lines 3. >3 B-lines 4. Confluent B-lines 5. Lobar consolidation * C: Noted if subpleural consolidation present * E: Noted if pleural effusion present | Behavioural | standard vaping cessation counseling (SOC) + ultrasound (US) |
Primary outcome
Lung Ultrasound Findings
Time frame: Day 1
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 1. 1 well-defined B-line 2. 2-3 well-defined B-lines 3. >3 B-lines 4. Confluent B-lines 5. Lobar consolidation * C: Noted if subpleural consolidation present * E: Noted if pleural effusion present
Behavioral Changes
Time frame: Day 1, at 2 weeks, at 2 months
Questionnaire to assess if observing lung findings can alter adolescents' vaping behaviors, risk perception, behavioral intent, and motivation to quit.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Background: PubMed 27773711Gorukanti 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.
- Background: PubMed 32715837Overbeek 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.
- Background: PubMed 31200279Fadus 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.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Discussion of point-of-care ultrasound lung findings in people with Vaping, run by Medical University of South Carolina at 1 site in United States.
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 4 inclusion and 14 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: finished, as of the sponsor's last update on 17 Feb 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung Ultrasound Findings (time frame: Day 1). The study lists 2 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 NCT06335329, which also lists 3 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 17 Feb 2026.