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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how vaping affects the lungs of adolescents. Researchers will use point-of-care ultrasound, a quick and non-invasive imaging test, to examine the lungs of young people who vape. They will assess whether showing these images can encourage quitting. Participants will receive either standard vaping cessation counseling or counseling combined with viewing their lung ultrasound images. Teens aged 12-18 who vape and speak English are ideal candidates for this study. As an unphased trial, this study offers a unique opportunity for participants to contribute to important research that could improve health outcomes for adolescents who vape.

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 prior data suggests that this ultrasound technique is safe for adolescents?

Research has shown that Point-of-Care Ultrasound (POCUS) is generally safe and well-tolerated. Studies have used POCUS widely without causing major side effects. This non-invasive ultrasound, which doesn't involve surgery or entering the body, uses sound waves to create images and can detect issues that other tests might miss.

In this study on vaping, researchers use the ultrasound to examine the lungs. No evidence suggests this poses any risk to participants. POCUS is commonly used in medical settings, including emergency rooms, because it is safe and effective. Participants in this study can feel confident that the ultrasound part of the trial is safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to enhance vaping cessation. Unlike standard options like counseling and nicotine replacement therapies, this trial investigates the impact of using Point-of-Care Ultrasound (POCUS) alongside standard counseling. This method allows participants to engage with real-time images and discussions about their lung health, potentially increasing motivation to quit. By visualizing the immediate effects of vaping on the lungs, researchers hope this approach will provide a more compelling reason for users to stop vaping compared to traditional methods alone.

What evidence suggests that this trial's treatments could be effective for vaping cessation?

Research shows that when patients view images of their own health, such as ultrasound scans, they may feel encouraged to quit harmful habits. Previous studies with adults found that seeing their ultrasound results increased their motivation to stop smoking. For pregnant patients, viewing real-time ultrasound images that showed how smoking affected their unborn child led to a significant reduction in smoking. In this trial, one group of participants will receive standard vaping cessation counseling (SOC) alone, while another group will receive SOC along with a discussion of their lung ultrasound (US) findings. Point-of-Care Ultrasound (POCUS) has proven useful in identifying and treating lung problems in children and critically ill patients. This suggests that using ultrasound to demonstrate vaping's impact on the lungs could help teenagers reconsider their vaping habits. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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