The Respiratory Protection Effectiveness Clinical Trial (ResPECT): a cluster-randomized comparison of respirator and medical mask effectiveness against respiratory infections in healthcare personnel

BMC Infectious Diseases

Study Protocol

Ann-Christine Nyquist¹  Connie Savor-Price²  Nicholas G. Reich³  Derek A. Cummings⁴  Trish M. Perl⁵  Charlotte Gaydos⁵  Maria Rodrigues-Barradas⁶  Ronald E. Shaffer⁷  Lewis J. Radonovich⁸  Aaron Eagan⁸  Mary T. Bessesen⁹  Cynthia Gibert^1,10  Michael S. Simberkoff^1,11  Geoffrey J. Gorse^1,12 

[1] Children’s Hospital Colorado, Aurora, CO, USA;University of Colorado School of Medicine, Denver, CO, USA;Denver Health, Denver, CO, USA;University of Colorado School of Medicine, Denver, CO, USA;Department of Biostatistics and Epidemiology, University of Massachusetts, Amherst, MA, USA;Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA;University of Florida, Gainesville, Florida, USA;Johns Hopkins School of Medicine, Baltimore, MD, USA;Michael E. DeBakey VAMC and Baylor College of Medicine, Houston, Texas, USA;National Personal Protective Technology Laboratory, National Institute for Occupational Safety and Health, Pittsburgh, PA, USA;U.S. Department of Veterans Affairs, National Center for Occupational Health and Infection Control, 1601 SW Archer Road, Mailstop 151E, 32608, Gainesville, FL, USA;Veterans Affairs Eastern Colorado Healthcare System, Denver, CO, USA;University of Colorado School of Medicine, Denver, CO, USA;Veterans Affairs Medical Center and George Washington University School of Medical and Health Sciences, Washington, DC, USA;Veterans Affairs New York Harbor Healthcare System, New York, NY, USA;Veterans Affairs St. Louis Healthcare System and Saint Louis University School of Medicine, St. Louis, MO, USA;

关键词: Respirators;    Masks;    Healthcare personnel;    Influenza;    Respiratory infections;   

DOI  :  10.1186/s12879-016-1494-2

 received in 2015-10-06, accepted in 2016-02-18,  发布年份 2016

来源: Springer

【 摘 要 】

BackgroundAlthough N95 filtering facepiece respirators and medical masks are commonly used for protection against respiratory infections in healthcare settings, more clinical evidence is needed to understand the optimal settings and exposure circumstances for healthcare personnel to use these devices. A lack of clinically germane research has led to equivocal, and occasionally conflicting, healthcare respiratory protection recommendations from public health organizations, professional societies, and experts.MethodsThe Respiratory Protection Effectiveness Clinical Trial (ResPECT) is a prospective comparison of respiratory protective equipment to be conducted at multiple U.S. study sites. Healthcare personnel who work in outpatient settings will be cluster-randomized to wear N95 respirators or medical masks for protection against infections during respiratory virus season. Outcome measures will include laboratory-confirmed viral respiratory infections, acute respiratory illness, and influenza-like illness. Participant exposures to patients, coworkers, and others with symptoms and signs of respiratory infection, both within and beyond the workplace, will be recorded in daily diaries. Adherence to study protocols will be monitored by the study team.DiscussionResPECT is designed to better understand the extent to which N95s and MMs reduce clinical illness among healthcare personnel. A fully successful study would produce clinically relevant results that help clinician-leaders make reasoned decisions about protection of healthcare personnel against occupationally acquired respiratory infections and prevention of spread within healthcare systems.Trial registrationThe trial is registered at clinicaltrials.gov, number NCT01249625 (11/29/2010).

【 授权许可】

CC BY   
© Radonovich et al. 2016