Clinical trial NCT06335329: Point-of-Care Ultrasound (POCUS) Findings and Impact on Vaping
Official title: Point-of-Care Ultrasound Findings and Impact on Vaping Behaviors in Adolescents
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vaping
Keywords: vaping
Point-of-care ultrasound
adolescents
POCUS
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 200
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Lung Ultrasound Findings
timeFrame: Day 1
measure: Behavioral Changes
timeFrame: Day 1, at 2 weeks, at 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.