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

Not Applicable

Completed

• Conditions: Influenza
• Interventions: Device: N95 mask; Device: Surgical mask

• Registration Number: NCT00756574
• Lead Sponsor: McMaster University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-09-19
• Study First Submitted QC: 2008-09-19
• Study First Posted: 2008-09-22
• Study Start: 2008-10
• Primary Completion: 2009-04
• Study Completion: 2009-05
• Results First Submitted: 2009-07-15
• Results First Submitted QC: 2009-07-15
• Results First Posted: 2009-08-21
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-25
• Last Update Posted: 2018-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 447

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2. N95 Respirator	N95 mask	N95 respirator
1. Surgical	Surgical mask	surgical mask

Primary Outcome Measures

Name	Time	Method
Laboratory-confirmed Influenza Infection	one year	Laboratory confirmed influenza

Secondary Outcome Measures

Name	Time	Method
Physician Visits for Respiratory Illness	one year	visit to primary care MD
Influenza-like Illness	Over entire study period	Cough and fever
Absenteeism	over study period	Absent from work because of flu-like illness

Trial Locations

Locations (1)

Hamilton Health Science; 🇨🇦 Hamilton, Ontario, Canada