The Differential Pattern of Deposition of Nano Particles in the Airways of Exposed Workers (Nanoexposure)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01599845
First received: April 29, 2012
Last updated: May 14, 2012
Last verified: May 2012
  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)

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • 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
Study Population

Patients

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01599845

Contacts
Contact: Yehuda Schwarz, M.D. 03-6973774 schwarz.reot@gmail.com

Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
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 August 27, 2014