Evaluation of Free Air Portable Air Powered Respirator

Status Completed

Clinical Trial Summary

This study will compare the efficacy of the Free Air Portable Air Powered Respirator (PAPR) system versus a N95 mask in preventing nasal detection of influenza following an exposure. The investigators hypothesize the use of the Free Air PAPR system will be superior to a N95 respirator at interrupting the exposure of the study participants to aerosolized influenza virus particles.

Clinical Trial Description

Airborne transmission represents one of the most rapidly spreading and least understood dissemination mechanisms for pathogens. Public health strategies to prevent and control the often explosive outbreaks associated with such pathogens are: 1) vaccination and treatment, if available, 2) decontamination of the exposed areas and surfaces, and 3) isolation and barrier precautions such as face masks. Unfortunately, evidence of the efficacy of currently recommended barrier precautions is currently lacking. Attempts to validate the effectiveness of personal protective equipment are limited to in vitro experiments with mannequin heads. This human exposure study will provide a much more accurate life-like exposure scenario. The use of live attenuated influenza virus vaccine has been proven to be safe. Objectives: Evaluate the Free Air Portable Air Powered Respirator (PAPR) versus an N95 face mask for preventing the airborne cross-transmission of aerosolized influenza in human participants. Methods: Participants will be randomized to one of two arms: a) N95 respirator, or b) Free Air PAPR System. The primary outcome will be the rate of the transmission for the 2 study groups, so a nasal and nasopharyngeal swab will be performed immediately following the exposure. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02487147
Study type	Interventional
Source	Wake Forest University Health Sciences
Contact
Status	Completed
Phase	N/A
Start date	November 14, 2016
Completion date	December 12, 2016

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