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

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00756574
• Other study ID #: 6273-15-2008
• Status: Completed
• Phase: N/A
• Start date: October 2008
• Est. completion date: May 2009

Study information

• Verified date: October 2018
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 447
• Est. completion date: May 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Device:
• Surgical mask
Surgical mask worn for patients with febrile respiratory illness
• N95 mask
N95 mask worn for patients with febrile respiratory illness

Locations

Country	Name	City	State
Canada	Hamilton Health Science	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Health Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Laboratory-confirmed Influenza Infection	Laboratory confirmed influenza	one year
Secondary	Physician Visits for Respiratory Illness	visit to primary care MD	one year
Secondary	Influenza-like Illness	Cough and fever	Over entire study period
Secondary	Absenteeism	Absent from work because of flu-like illness	over study period