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

Primary Purpose

Influenza

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Surgical mask

N95 mask

About this trial

This is an interventional prevention trial for Influenza focused on measuring N95, Respirator, mask, influenza, efficacy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Hamilton Health Science

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

1. Surgical

2. N95 Respirator

Arm Description

surgical mask

N95 respirator

Outcomes

Primary Outcome Measures

Laboratory-confirmed Influenza Infection

Laboratory confirmed influenza

Secondary Outcome Measures

Physician Visits for Respiratory Illness

visit to primary care MD

Influenza-like Illness

Cough and fever

Absenteeism

Absent from work because of flu-like illness

Full Information

NCT ID

NCT00756574

First Posted

September 19, 2008

Last Updated

October 25, 2018

Sponsor

McMaster University

Collaborators

Health Canada

1. Study Identification

Unique Protocol Identification Number

NCT00756574

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

October 2008 (undefined)

Primary Completion Date

April 2009 (Actual)

Study Completion Date

May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

McMaster University

Collaborators

Health Canada

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza

Keywords

N95, Respirator, mask, influenza, efficacy

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

447 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1. Surgical

Arm Type

Active Comparator

Arm Description

surgical mask

Arm Title

2. N95 Respirator

Arm Type

Active Comparator

Arm Description

N95 respirator

Intervention Type

Device

Intervention Name(s)

Surgical mask

Intervention Description

Surgical mask worn for patients with febrile respiratory illness

Intervention Type

Device

Intervention Name(s)

N95 mask

Intervention Description

N95 mask worn for patients with febrile respiratory illness

Primary Outcome Measure Information:

Title

Laboratory-confirmed Influenza Infection

Description

Laboratory confirmed influenza

Time Frame

one year

Secondary Outcome Measure Information:

Title

Physician Visits for Respiratory Illness

Description

visit to primary care MD

Time Frame

one year

Title

Influenza-like Illness

Description

Cough and fever

Time Frame

Over entire study period

Title

Absenteeism

Description

Absent from work because of flu-like illness

Time Frame

over study period

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark Loeb, MD, MSc

Organizational Affiliation

Hamilton Health Sciences - McMaster University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hamilton Health Science

City

Hamilton

State/Province

Ontario

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

19797474

Citation

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.

Results Reference

derived

Learn more about this trial

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

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