Randomized Control Trial to Study the Efficacy of the Surgical Mask Versus the N95 Respirator to Prevent Influenza - Full Text View

Sponsors and Collaborators:	Hamilton Health Sciences Health, Canada
Information provided by:	McMaster University
ClinicalTrials.gov Identifier:	NCT00756574

Purpose

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.

Condition	Intervention
Influenza	Device: Surgical mask Device: N95 mask

MedlinePlus related topics: Flu Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized Control Trial of Surgical Masks vs N95 Respirators to Prevent Influenza in Health Care Workers

Further study details as provided by McMaster University:

Primary Outcome Measures:

Laboratory-confirmed influenza infection [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

In addition to laboratory-confirmed influenza, the investigators will assess influenza-like illness, work- related absenteeism, physician visits for respiratory illness, and lower respiratory infection or pneumonia. [ Time Frame: oney year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	420
Study Start Date:	October 2008
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1. Surgical: Active Comparator surgical mask	Device: Surgical mask Surgical mask worn for patients with febrile respiratory illness
2. N95 Respirator: Active Comparator N95 respirator	Device: N95 mask N95 mask worn for patients with febrile respiratory illness

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00756574

Contacts

Contact: Nancy E Dafoe, RN

905 902 9519

dafoe@hhsc.ca

Locations

Canada, Ontario
Hamilton Health Science
Hamilton, Ontario, Canada

Sponsors and Collaborators

Hamilton Health Sciences

Health, Canada

Investigators

Principal Investigator:

Mark Loeb, MD, MSc

Hamilton Health Sciences - McMaster University

More Information

No publications provided

Responsible Party:	Department of Pathology and Molecular Medicine, McMaster University, Hamilton ON ( Dr. Mark Loeb )
Study ID Numbers:	6273-15-2008
Study First Received:	September 19, 2008
Last Updated:	September 19, 2008
ClinicalTrials.gov Identifier:	NCT00756574 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by McMaster University:

N95
Respirator
mask
influenza
efficacy

Study placed in the following topic categories:

Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

Additional relevant MeSH terms:

Virus Diseases
RNA Virus Infections
Respiratory Tract Diseases

Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

ClinicalTrials.gov processed this record on May 07, 2009