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NCT Number: NCT00756574

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

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hamilton Health Science

Hamilton, Ontario, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgical mask

Device

Surgical mask worn for patients with febrile respiratory illness

N95 mask

Device

N95 mask worn for patients with febrile respiratory illness

Primary outcomes

  1. Laboratory-confirmed Influenza Infection

    Time frame: one year

    Laboratory confirmed influenza

Secondary outcomes

  1. Physician Visits for Respiratory Illness

    Time frame: one year

    visit to primary care MD

  2. Influenza-like Illness

    Time frame: Over entire study period

    Cough and fever

  3. Absenteeism

    Time frame: over study period

    Absent from work because of flu-like illness

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Health Canada

Registry information

Official study title

A Randomized Control Trial of Surgical Masks vs N95 Respirators to Prevent Influenza in Health Care Workers

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Sep 22, 2008
Registry last updated
Oct 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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