- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01639235
Effects of Secondhand Smoke on Flight Attendant Health (FAMRI)
January 25, 2021 updated by: University of California, San Francisco
Cardiopulmonary Effects of Secondhand Smoke Exposure on Flight Attendants
This is a study on a population of flight attendants who were exposed to occupational secondhand tobacco smoke (SHS).
This research will examine associations between flight attendant SHS exposure and development of respiratory illnesses, reproductive problems, and cardiovascular diseases.
Study Overview
Status
Completed
Conditions
Detailed Description
The main hypothesis of this study is that exposure to the secondhand tobacco smoke (SHS) in the confined workspace of commercial aircraft prior to the ban of cigarette smoking is responsible for long-term damage on the health of nonsmoking flight attendants.
We will compare the data collected from our pre-ban flight attendant participants to age-matched, nonsmoking controls from the NHANES (National Health and Nutrition Examination Survey) database.
The results of our study should permit us to determine if SHS exposure is the cause of long-term increased cardiovascular morbidity and risk, as well as increased susceptibility to respiratory illnesses.
Study Type
Observational
Enrollment (Actual)
592
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Francisco, California, United States, 94143
- University of California, San Francisco
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
This is a cross-sectional observational study of flight attendants exposed to secondhand tobacco smoke.
Description
Inclusion Criteria:
- Never smoker flight attendants who began working for airlines before the smoking ban on aircrafts went into effect. Never smoker is defined as those with history of tobacco use of less than 100 cigarettes in their lifetime.
- SHS exposure for at least 1 year while working with the airlines.
Exclusion Criteria:
- Less than 1 year of occupational exposure to SHS
- Smoking more than 100 cigarettes over a lifetime
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Characterize the long-term effects of SHS on lung and cardiovascular function in pre-ban flight attendants
Time Frame: 25 minutes
|
A spirometry test is performed by the Clinical Research Coordinator to establish the lung function of the flight attendant participant and medical assistants from the cardiovascular care clinic administer a 12-lead non-invasive electrocardiogram.
|
25 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Examination
Time Frame: 30 min
|
The cardiologist performs a noninvasive assessment of the patient's vascular function, which includes a brief physical examination, blood pressure measurement, pulse, and oxygen level.
|
30 min
|
Characterize the long term effects of prolonged flight time and SHS on reproductive health
Time Frame: 10 minutes
|
Flight attendants fill out the electronic Exposure Questionnaire prior to their appointments.
Part of the Questionnaire is a section on reproductive health.
The answers to these survey questions in addition to information gathered and saved in the local medical record system (APeX) during the clinic visit are used for analysis on reproductive health of flight attendants.
|
10 minutes
|
Characterize the biomarkers of SHS exposure
Time Frame: 10 minutes
|
A 45 mL blood specimen is drawn from interested patients to be stored in the research lab as well as analyzed in a University of California, San Francisco (UCSF) laboratory.
Results of the blood analysis performed in the research labs, such as secondhand smoke biomarkers and advanced lipid biomarkers, will not be shared with the subject.
|
10 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Rita Redberg, MD, University of California, San Francisco
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 31, 2005
Primary Completion (Actual)
December 31, 2020
Study Completion (Actual)
December 31, 2020
Study Registration Dates
First Submitted
July 9, 2012
First Submitted That Met QC Criteria
July 11, 2012
First Posted (Estimate)
July 12, 2012
Study Record Updates
Last Update Posted (Actual)
January 28, 2021
Last Update Submitted That Met QC Criteria
January 25, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-13934
- FAMRI (Other Grant/Funding Number: FAMRI (Flight Attendant Medical Research Institute))
- 146312 (Other Identifier: University of California, San Francisco)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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