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

This study has been completed.
Sponsor:
Collaborator:
Health Canada
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00756574
First received: September 19, 2008
Last updated: July 15, 2009
Last verified: July 2009
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Randomized Control Trial of Surgical Masks vs N95 Respirators to Prevent Influenza in Health Care Workers

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Laboratory-confirmed Influenza Infection [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physician Visits for Respiratory Illness [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • Influenza-like Illness [ Time Frame: Over entire study period ] [ Designated as safety issue: No ]
  • Absenteeism [ Time Frame: over study period ] [ Designated as safety issue: No ]

Enrollment: 447
Study Start Date: October 2008
Study Completion Date: May 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1. Surgical
surgical mask
Device: Surgical mask
Surgical mask worn for patients with febrile respiratory illness
Active Comparator: 2. N95 Respirator
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Canada, Ontario
Hamilton Health Science
Hamilton, Ontario, Canada
Sponsors and Collaborators
McMaster University
Health Canada
Investigators
Principal Investigator: Mark Loeb, MD, MSc Hamilton Health Sciences - McMaster University
  More Information

No publications provided by McMaster University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Mark Loeb, Department of Pathology and Molecular Medicine, McMaster University, Hamilton ON
ClinicalTrials.gov Identifier: NCT00756574     History of Changes
Other Study ID Numbers: 6273-15-2008
Study First Received: September 19, 2008
Results First Received: July 15, 2009
Last Updated: July 15, 2009
Health Authority: Canada: Health Canada

Keywords provided by McMaster University:
N95
Respirator
mask
influenza
efficacy

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 27, 2014