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

Vaping Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06335329
• Other study ID #: Pro00133616
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: July 2025

Study information

• Verified date: April 2024
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Vaping

Intervention

Behavioral:
• Discussion of point-of-care ultrasound lung findings
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

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Day 1
Primary	Behavioral Changes	Questionnaire to assess if observing lung findings can alter adolescents' vaping behaviors, risk perception, behavioral intent, and motivation to quit.	Day 1, at 2 weeks, at 2 months