Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06335329
Status:
RECRUITING
Last Update Posted:
2024-04-02
First Post:
2024-03-14
Brief Title:
Point-of-Care Ultrasound POCUS Findings and Impact on Vaping
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
Point-of-Care Ultrasound Findings and Impact on Vaping Behaviors in Adolescents
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 21 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 vapinge-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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None