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OpenTrials
Completed

NCT Number: NCT06335329

Point-of-Care Ultrasound (POCUS) Findings and Impact on Vaping

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.

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Key information

Conditions

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29412, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Discussion of point-of-care ultrasound lung findings

Behavioral

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

Primary outcomes

  1. 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 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
  2. 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.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

Point-of-Care Ultrasound Findings and Impact on Vaping Behaviors in Adolescents

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 28, 2024
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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