The Differential Pattern of Deposition of Nano Particles in the Airways of Exposed Workers (Nanoexposure)
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Purpose
Investigation of the differences between the levels of extracellular and intracellular nano-particles in workers exposed to environmental particles during their employment to enhance understanding the process of penetration of the particles to respiratory epithelial cells.
| Condition |
|---|
|
Inadequate or Impaired Respiratory Function |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Cross-Sectional |
| Official Title: | The Differential Pattern of Deposition of Nano Particles in the Airways of Exposed Workers (Nanoexposure) |
- Analysis of the size distribution of nano-particles in exhaled breath condensate [ Time Frame: One year ] [ Designated as safety issue: Yes ]Each subject will be examined once. The total time for collection of data is estimated as about one year.
| Estimated Enrollment: | 60 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Nanoparticle exposed |
Detailed Description:
This study investigates the following questions:
Does occupational exposure to nanoparticles influence permeation of such particles to respiratory airways? Is there a correlation between the levels of nanoparticles in sample biological fluids of the patients and their pulmonary functions.
Is there a correlation between the levels of nanoparticles in sample biological fluids of the patients and respiratory tract infections.
The study protocol includes the following steps:
Initial interview of the patient Measurement of nanoparticles in samples of exhaled breath condensate using NanoSight LM 20 Measurement of nanoparticles in induced sputum. And finally examination of the relationship between the measured parameters and the indices of pulmonary infection, and pulmonary function as measured by the pulmonary department of the TASMC.
Eligibility| Ages Eligible for Study: | 20 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Patients
Inclusion Criteria:
- Adults over 20 years of age who visit Ichilov Hospital for medical complaints/inquiries regarding respiratory tract.
- Study population is composed of people who are exposed to environmental particles form industrial sources.
- Informed consent is requested from each subject.
Exclusion Criteria:
- Unemployed individuals.
- Individuals who are not working in industrial jobs, such as office workers and secretaries.
Contacts and Locations| Contact: Yehuda Schwarz, M.D. | 03-6973774 | schwarz.reot@gmail.com |
| Principal Investigator: | Yehuda Schwarz, M.D. | Tel Aviv Sourasky Medical Center (TASMC, Ichilov) |
More Information
No publications provided
| Responsible Party: | Tel-Aviv Sourasky Medical Center |
| ClinicalTrials.gov Identifier: | NCT01599845 History of Changes |
| Other Study ID Numbers: | TASMC-11-YS-0107-CTIL |
| Study First Received: | April 29, 2012 |
| Last Updated: | May 14, 2012 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by Tel-Aviv Sourasky Medical Center:
|
Lung Alveoli Nanoparticles Particulate matter |
Exhaled breath condensate Induced sputum Forced expiratory volume Force vital capacity |
ClinicalTrials.gov processed this record on October 17, 2012
