Randomized Control Trial to Study the Efficacy of the Surgical Mask Versus the N95 Respirator to Prevent Influenza

McMaster University

Status: Completed

Conditions: Influenza

Treatments: Device: Surgical mask; Device: N95 mask

Study type: Interventional

Funder types: Other

Identifiers

NCT00756574

6273-15-2008

Details and patient eligibility

About

The goal of this study is to compare the efficacy of the surgical mask to the N95 respirator in protecting nurses from influenza in the hospital setting. The investigators propose a non-inferiority randomized controlled trial whereby nurses are randomized to either a surgical mask or an N95 respirator when caring for patients with febrile respiratory illness during the influenza season. The hypothesis is that the surgical mask offers similar protection against influenza to that of the N95. The specific objective of the study is to assess whether the rates of influenza (laboratory-confirmed by PCR and HAI assay), as well as secondary outcomes (influenza-like illness, work-related absenteeism, physician visits for respiratory illness, and lower respiratory infection), are similar among nurses using a surgical mask compared to those using an N95 respirator.

Enrollment: 447 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Nurses who work in emergency departments and medical units
• Nurses expected to work full time (defined as > 37 hours per week)

Exclusion criteria

• Nurses who were not fit tested
• Nurses who could not pass a fit test

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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447 participants in 2 patient groups

1. Surgical

Active Comparator group

Description:

surgical mask

Treatment:

Device: Surgical mask

2. N95 Respirator

Active Comparator group

Description:

N95 respirator

Treatment:

Device: N95 mask