Status:
COMPLETED
Electronic Nicotine Delivery Devices and Potential Progression to Acute Lung Injury
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Acute Lung Injury
Pulmonary Injury
Eligibility:
All Genders
18-80 years
Brief Summary
This is an observational - data and specimen collection study. There have been increasing reports of vaping-induced lung injury, including severe lung injury and rare cases of death. The mechanism by ...
Detailed Description
Participants will be consented and undergo collection of data and specimens as listed below. * Vaping use will be determined by history. * No administration, dispensing or use of any vape product wil...
Eligibility Criteria
Inclusion
- Men and women age 18 to 80
- Participant in a previous HLRC study, or a participant in the HIV PACT clinic or referred by a PACCM physician
- At least weekly vape use over the past 3 months
- OR No previous history of vape use and no current history of smoking tobacco for controls
- negative pregnancy test (for women of child barring capabilities)
Exclusion
- pregnancy or breast-feeding (urine pregnancy done on all females of child bearing potential- - - males and females who are at least 1 year post menopausal or surgically sterile will not be tested)
- Contraindication to pulmonary function testing (i.e. abdominal or cataract surgery within 3 months, recent myocardial infarction, etc.).
- Increasing respiratory symptoms or febrile (temperature \>100.40F \[380C\]) within 4 weeks of study entry.
- Acute cardiopulmonary issue in the past 4 months.
- Uncontrolled hypertension at screening visit (systolic \> 180 mm Hg or diastolic \> 100 mm Hg) from an average of two or more readings. Subject may return for screening after blood pressure is controlled.
- Active cancer requiring systemic chemotherapy or radiation.
- Active infection of lungs, brain, or abdomen.
- Intravenous drug use or alcohol use that will impair ability to complete study investigations in the opinion of the investigator.
- subjects with an upper or lower respiratory tract infection
- Persons who have tested positive for Covid 19 in the past 4 weeks.
Key Trial Info
Start Date :
November 15 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2024
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT05316727
Start Date
November 15 2021
End Date
December 1 2024
Last Update
January 28 2025
Active Locations (1)
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1
University of Pittsburgh department of medicine division of Pulmonary, Allergy and Critical Care medicine
Pittsburgh, Pennsylvania, United States, 15213