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

NCT ID: NCT00756574

Last Updated: 2018-10-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

447 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-05-31

Brief Summary

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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

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Conditions

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Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1. Surgical

surgical mask

Group Type ACTIVE_COMPARATOR

Surgical mask

Intervention Type DEVICE

Surgical mask worn for patients with febrile respiratory illness

2. N95 Respirator

N95 respirator

Group Type ACTIVE_COMPARATOR

N95 mask

Intervention Type DEVICE

N95 mask worn for patients with febrile respiratory illness

Interventions

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Surgical mask

Surgical mask worn for patients with febrile respiratory illness

Intervention Type DEVICE

N95 mask

N95 mask worn for patients with febrile respiratory illness

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Health Canada

OTHER_GOV

Sponsor Role collaborator

McMaster University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark Loeb, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Hamilton Health Sciences - McMaster University

Locations

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Hamilton Health Science

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

References

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Loeb M, Dafoe N, Mahony J, John M, Sarabia A, Glavin V, Webby R, Smieja M, Earn DJ, Chong S, Webb A, Walter SD. Surgical mask vs N95 respirator for preventing influenza among health care workers: a randomized trial. JAMA. 2009 Nov 4;302(17):1865-71. doi: 10.1001/jama.2009.1466. Epub 2009 Oct 1.

Reference Type DERIVED
PMID: 19797474 (View on PubMed)

Other Identifiers

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6273-15-2008

Identifier Type: -

Identifier Source: org_study_id

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