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

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

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.

Study Overview

• Status: Unknown
• Conditions: Inadequate or Impaired Respiratory Function

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.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Yehuda Schwarz, M.D.; Phone Number: 03-6973774; Email: schwarz.reot@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Nanoparticle exposed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analysis of the size distribution of nano-particles in exhaled breath condensate	Each subject will be examined once. The total time for collection of data is estimated as about one year.	One year

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center
• Investigators: Principal Investigator: Yehuda Schwarz, M.D., Tel Aviv Sourasky Medical Center (TASMC, Ichilov)

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): May 1, 2013

Study Registration Dates

• First Submitted: April 29, 2012
• First Submitted That Met QC Criteria: May 14, 2012
• First Posted (Estimate): May 16, 2012

Study Record Updates

• Last Update Posted (Estimate): May 16, 2012
• Last Update Submitted That Met QC Criteria: May 14, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: Lung; Particulate matter; Induced sputum; Exhaled breath condensate; Nanoparticles; Forced expiratory volume; Alveoli; Force vital capacity
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: TASMC-11-YS-0107-CTIL