The Respiratory Protection Effectiveness Clinical Trial

Completed · Not applicable

Conditions studied: Influenza, Respiratory Syncytial Viruses, Paramyxoviridae Infections, Coronavirus, Rhinovirus

In brief

Despite widespread use of respiratory protective equipment in the U.S. healthcare workplace, there is very little clinical evidence that respirators prevent healthcare personnel (HCP) from airborne infectious diseases. Scientific investigation of this issue has been quite complicated, primarily because the use of respirators has become "the standard of care" for protection against airborne diseases in some instances, even without sufficient evidence to support their use. The key question remains: How well do respirators prevent airborne infectious diseases? The answer to this important question has important medical, public health, political and economic implications.

Key facts

Study ID

NCT01249625

Run by

Johns Hopkins University

People needed

2862

Starts

2010-12-01

Expected to finish

2018-03-01

Last updated by the study team

2019-04-25

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical site leadership has agreed to have one or more staff participate in the trial
• Subject meets the definition of "healthcare personnel"
• Subject able to read and sign informed consent
• Subject agrees to all requirements of the protocol, including fit testing and diary keeping
• Subject's age is 18 or greater
• Subject passes fit testing for one of the study supplied respirator models and agrees to use that model for the entire intervention period of the study (if in respirator arm).

You may not qualify if…

• Subject self-identified as having severe heart, lung, neurological or other systemic disease that one or more Investigator believes could preclude safe participation
• Known to not tolerate wearing respiratory protective equipment for any period
• Facial hair, or other issue such as facial adornments, precluding respirator OSHA-compliant fit testing or proper mask fit during the study period
• Advised by Occupational Health (or other qualified clinician) to not wear the same or similar respirator or medical mask models used in this study
• In the opinion of the Investigator, may not be able to reasonably participate in the trial for any reason
• Self-identified as in, or will be in the third trimester of pregnancy, during the study period.
• Subject rotating in 2 different ResPECT study clinic sites /clusters during the 12-week study period.
• Subject works less than 75% of the intervention period in that clinic.
• Subject is a previous participant of the ResPECT Study, but does not consent for data from previous flu season(s) to be linked.

Where it is running

• Children's Hospital Colorado Infectious Disease — Aurora, Colorado, United States
• Denver Health Medical Center — Denver, Colorado, United States
• Denver Veteran's Administration Medical Center — Denver, Colorado, United States
• Veterans Affairs Medical Center, Washington, DC — Washington D.C., District of Columbia, United States
• Johns Hopkins Health Sytstem — Baltimore, Maryland, United States
• VA New York Harbor Healthcare System — New York, New York, United States
• Houston VA Medical Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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