• JAMA · Nov 2009

    Randomized Controlled Trial Multicenter Study Comparative Study

    Surgical mask vs N95 respirator for preventing influenza among health care workers: a randomized trial.

    • Mark Loeb, Nancy Dafoe, James Mahony, Michael John, Alicia Sarabia, Verne Glavin, Richard Webby, Marek Smieja, David J D Earn, Sylvia Chong, Ashley Webb, and Stephen D Walter.
    • Department of Pathology and Molecular Medicine, McMaster University, Hamilton, Ontario, Canada.
    • JAMA. 2009 Nov 4;302(17):1865-71.

    ContextData about the effectiveness of the surgical mask compared with the N95 respirator for protecting health care workers against influenza are sparse. Given the likelihood that N95 respirators will be in short supply during a pandemic and not available in many countries, knowing the effectiveness of the surgical mask is of public health importance.ObjectiveTo compare the surgical mask with the N95 respirator in protecting health care workers against influenza.Design, Setting, And ParticipantsNoninferiority randomized controlled trial of 446 nurses in emergency departments, medical units, and pediatric units in 8 tertiary care Ontario hospitals.InterventionAssignment to either a fit-tested N95 respirator or a surgical mask when providing care to patients with febrile respiratory illness during the 2008-2009 influenza season.Main Outcome MeasuresThe primary outcome was laboratory-confirmed influenza measured by polymerase chain reaction or a 4-fold rise in hemagglutinin titers. Effectiveness of the surgical mask was assessed as noninferiority of the surgical mask compared with the N95 respirator. The criterion for noninferiority was met if the lower limit of the 95% confidence interval (CI) for the reduction in incidence (N95 respirator minus surgical group) was greater than -9%.ResultsBetween September 23, 2008, and December 8, 2008, 478 nurses were assessed for eligibility and 446 nurses were enrolled and randomly assigned the intervention; 225 were allocated to receive surgical masks and 221 to N95 respirators. Influenza infection occurred in 50 nurses (23.6%) in the surgical mask group and in 48 (22.9%) in the N95 respirator group (absolute risk difference, -0.73%; 95% CI, -8.8% to 7.3%; P = .86), the lower confidence limit being inside the noninferiority limit of -9%.ConclusionAmong nurses in Ontario tertiary care hospitals, use of a surgical mask compared with an N95 respirator resulted in noninferior rates of laboratory-confirmed influenza.Trial Registrationclinicaltrials.gov Identifier: NCT00756574

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