Ultrasound Findings for Vaping

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Disqualifiers: Chronic lung disease, Cancer, Sickle cell, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

200 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Point-of-Care Ultrasound (POCUS) for vaping-related conditions?

Research shows that Point-of-Care Ultrasound (POCUS) is effective in diagnosing and managing respiratory issues in children and critically ill patients, which suggests it could be useful for assessing lung problems related to vaping. POCUS is a quick and cost-effective tool that helps doctors make immediate decisions in emergency and critical care settings. ^{1 2 3 4 5}

How does this treatment differ from other treatments for vaping-related lung injury?

This treatment is unique because it focuses on using ultrasound to identify lung damage caused by vaping, which is different from traditional methods that rely on chest X-rays or CT scans. Ultrasound may offer a non-invasive and immediate way to detect lung issues in patients who vape, potentially leading to quicker diagnosis and treatment. ^{6 7 8 9 10}

Eligibility Criteria

This trial is for adolescents who vape and are interested in learning about the potential impact on their lungs. Participants should be asymptomatic, meaning they don't currently have any symptoms of lung issues. There's no mention of specific exclusion criteria, so generally healthy vaping adolescents may qualify.

Inclusion Criteria

Able to speak and understand English

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)

Exclusion Criteria

I have recently experienced a chest injury.

Inability or unwillingness of subject or legal guardian/representative to give informed consent/assent

Known allergy or sensitivity to ultrasound gel

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline lung ultrasound to evaluate lung findings

1 day

1 visit (in-person)

Intervention

Participants receive standard vaping cessation counseling, with or without ultrasound feedback

2 months

3 visits (in-person)

Follow-up

Participants are monitored for changes in vaping behaviors and lung ultrasound findings

2 months

2 visits (in-person)

Treatment Details

Interventions

• Point-of-Care Ultrasound (POCUS)

Trial Overview The study is looking at how showing young vapers ultrasound images of their lungs might change their views on vaping and potentially lead them to quit. It's based on previous studies where visual feedback motivated adults to stop smoking or led pregnant women to reduce smoking.

Participant Groups

Group I: Standard vaping cessation counseling (SOC) alone Active Control 1 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.

Group II: standard vaping cessation counseling (SOC) + ultrasound (US) Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Findings from Research

Point of care ultrasound (POCUS) is a valuable tool in pediatric emergency medicine, particularly for diagnosing and assessing respiratory issues in children of all ages, from neonates to older kids.

The article emphasizes the practical benefits of using POCUS in everyday pediatric practice, including its ability to provide immediate diagnostic information and evaluate the effectiveness of treatments for respiratory distress and failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fifteen-minute consultation: Using point of care ultrasound to assess children with respiratory failure. Ord, HL., Griksaitis, MJ.[2020]

Non-physician performed ultrasound-guided peripheral intravenous access (USGPIVA) shows high success rates, especially in patients predicted to be difficult to cannulate, based on a review of 16 relevant studies.

This method can reduce the need for more invasive procedures like central venous catheterization, and paramedics, nurses, and emergency technicians can achieve competence with minimal training, highlighting its potential as a valuable tool in out-of-hospital settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can Non-Physician Providers Use Ultrasound to Aid in Establishing Peripheral IV Access in Patients Who are Difficult to Cannulate? A Scoping Review. Burton, SO., Donovan, JK., Jones, SL., et al.[2022]

A standardized lung ultrasound (LUS) training program was successfully implemented across eight international sites, training 49 sonographers and improving image quality for 486 participants, with over 80% of images deemed acceptable after training.

The study demonstrates that point-of-care ultrasound (POCUS) can be effectively utilized by a diverse range of providers, enhancing diagnostic capabilities in both resource-limited and well-equipped clinical settings, which could improve patient care in critical situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of an International Severe Infection Point-of-Care Ultrasound Research Network. Herrera, PM., Blair, PW., Siddharthan, T., et al.[2023]

The POCUS Working Group of ESPNIC developed evidence-based guidelines for using point-of-care ultrasound in critically ill neonates and children, reaching consensus on 39 out of 41 recommendations.

Most recommendations (28 out of 39) were based on moderate quality evidence, highlighting the need for further research and training to enhance the effectiveness and safety of POCUS in pediatric critical care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

International evidence-based guidelines on Point of Care Ultrasound (POCUS) for critically ill neonates and children issued by the POCUS Working Group of the European Society of Paediatric and Neonatal Intensive Care (ESPNIC). Singh, Y., Tissot, C., Fraga, MV., et al.[2021]

In a study across 142 ICUs involving 1954 patients, point-of-care ultrasound (POCUS) was performed on 36% of patients, primarily for diagnostic assessments (87%), demonstrating its critical role in patient care.

The diagnostic and therapeutic impacts of POCUS were significant, with 84% and 69% effectiveness, respectively, highlighting its importance in improving clinical outcomes in the ICU setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Point-of-care ultrasound in intensive care units: assessment of 1073 procedures in a multicentric, prospective, observational study. Zieleskiewicz, L., Muller, L., Lakhal, K., et al.[2022]

Vaping, particularly with electronic nicotine delivery systems (ENDS), is linked to serious lung injuries, including acute respiratory distress syndrome (ARDS), especially in young, otherwise healthy individuals.

Radiologists must recognize vaping as a potential cause of ARDS to ensure timely medical intervention and respiratory support, as evidenced by a case study presented in the paper.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaping-associated acute respiratory distress syndrome. Sakla, NM., Gattu, R., Singh, G., et al.[2020]

Over 2000 cases of vaping-associated lung injury have been reported, leading to more than 40 deaths, highlighting the serious health risks associated with vaping.

Chest imaging reveals that the most common pattern of lung injury from vaping includes basilar-predominant ground-glass opacities and consolidations, and radiologists should be aware of these patterns to aid in diagnosis, especially in patients who have vaped within 90 days of symptom onset.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiologic Review With Pathology Correlation of E-Cigarette or Vaping Product Use-associated Lung Injury. Bin Saeedan, M., MacMurdo, MG., Mukhopadhyay, S., et al.[2021]

A systematic review of 30 studies involving 184 participants revealed that the most common radiological findings in EVALI (e-cigarette or vaping product use associated lung injury) were bilateral infiltrates and ground glass opacities, indicating significant lung damage.

Only 28.4% of patients with follow-up data showed complete resolution of symptoms or radiological findings, highlighting the potential long-term impact of EVALI and the need for standardized diagnostic criteria in radiology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiological findings of e-cigarette or vaping product use associated lung injury: A systematic review. Sreedharan, S., Mian, M., Robertson, RA., et al.[2021]

In a study of nine young, asymptomatic e-cigarette users, MRI revealed that vaping significantly increased ventilation-perfusion (V̇A/Q̇) mismatch, indicating potential disruptions in lung function that normal spirometry tests might not detect.

The research found that e-cigarette users had greater V̇A/Q̇ mismatch both at baseline and after vaping, suggesting that even healthy individuals may experience subclinical lung function changes due to vaping.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaping disrupts ventilation-perfusion matching in asymptomatic users. Kizhakke Puliyakote, AS., Elliott, AR., Sá, RC., et al.[2022]

The rise of electronic nicotine delivery systems (ENDS) has led to a significant increase in acute lung injuries known as EVALI, particularly linked to the use of vitamin E acetate as a diluting agent in vaping products.

EVALI presents with a range of respiratory and systemic symptoms, and its diagnosis requires specific criteria, including recent vaping history and abnormal chest imaging, highlighting the need for early identification to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

E-cigarette or vaping product use-associated lung injury: A review of clinico-radio-pathological characteristics. Garg, I., Vidholia, A., Garg, A., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Fifteen-minute consultation: Using point of care ultrasound to assess children with respiratory failure. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Can Non-Physician Providers Use Ultrasound to Aid in Establishing Peripheral IV Access in Patients Who are Difficult to Cannulate? A Scoping Review. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Implementation of an International Severe Infection Point-of-Care Ultrasound Research Network. [2023]

4. England pubmed.ncbi.nlm.nih.gov

International evidence-based guidelines on Point of Care Ultrasound (POCUS) for critically ill neonates and children issued by the POCUS Working Group of the European Society of Paediatric and Neonatal Intensive Care (ESPNIC). [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Point-of-care ultrasound in intensive care units: assessment of 1073 procedures in a multicentric, prospective, observational study. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Vaping-associated acute respiratory distress syndrome. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Radiologic Review With Pathology Correlation of E-Cigarette or Vaping Product Use-associated Lung Injury. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Radiological findings of e-cigarette or vaping product use associated lung injury: A systematic review. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Vaping disrupts ventilation-perfusion matching in asymptomatic users. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

E-cigarette or vaping product use-associated lung injury: A review of clinico-radio-pathological characteristics. [2023]