USDOE Human Subjects Research Database, fiscal year 1995

Lawrence Livermore National Laboratory


Project Identification:

Project Identifier: LLNL-89-106

Project Title:

Protective Breathing Equipment (Respirators) Testing

Principle Investigator: Mr. Kenneth L. Foote

Project started in: 1989


Fiscal Year 1995 Funding for Research on Human Subjects:

Project Funding Information:
Project received funding in Fiscal Year 1995.
Project used human subjects in Fiscal Year 1995.

Funding Sources:

Non-Federal: E.D. Bullard Company
Amount: $50,000


Information on Use of Human Subjects:

Project does not involve use of multiple protocols/subprojects.

IRB Review:
Type of Review: Full Board
Most Recent Approval: March 22, 1995
IRB Approval Number: 89-106

Number of Human Subjects in the Last Reporting Period for this Project: 4
(Reporting periods vary.)

Type of Human Subjects Involvement:

Chemical Substances:

External use of chemical substances (solid, liquid, or gas) on human subjects.

Abstract:
(a. Objectives, b. Methodology, c. Ionizing Radiation, Radioactive Substances, or Chemical Substances to which human subjects are exposed, d. Involvement of Human Subjects [d.1. procedures used, d.2. risks if any])

The ability of the respirator to prevent leakage of outside contaminants into the breathing air will be measured by placing a human subject wearing a respirator in a test chamber containing a challenge atmosphere of air with one or more of the following added: 2000 parts per million (ppm) of sulfur hexafluoride gas, 2000 ppm of Freon 12 gas, 20 milligrams per cubic meter (mg/m3) polyethylene glycol 400 (PEG 400) aerosol, 20 mg/m3 of calcium carbonate aerosol, 20 mg/m3 of aluminum oxide, or 20 mg/m3 of polystyrene latex. These chemicals have been determined to be safe for respirator testing. The subject may be in the test chamber for up to 45 minutes while performing a variety of exercises and movements. Occasionally, subjects are asked to walk/run on a treadmill.

The ability of a respirator to provide sufficient breathing air of an adequate quality to its wearer will be determined in addition to its ability to prevent faceseal leakage. The sufficiency of breathing air will be determined by measuring the differential pressure between inside the facepiece and the atmosphere. The quality of the air will be determined by measuring the oxygen and carbon dioxide concentrations inside the facepiece when applicable. Oxygen and carbon dioxide concentrations as well as the subject's heart rate will be measured continuously and monitored by the experimenter to ensure the safety of the human subject. The subject's respiration rate will also be recorded. Conditions for terminating the tests will be: oxygen concentration below 16%, carbon dioxide concentration above 5%, heart rate above 90% of cardiac reserve at any time, heart rate above 80% of cardiac reserve for more than one minute, or at the request of the subject for any reason.

These tests will provide a better understanding of existing respirators. They will also assist in the development of new and improved respirators and will provide workers with a greater selection of respiratory protection devices and hopefully with greater protection from hazardous atmospheres.


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