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| Name | Class |
|---|---|
| Health Canada | OTHER_GOV |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. Surgical | Active Comparator | surgical mask |
|
| 2. N95 Respirator | Active Comparator | N95 respirator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical mask | Device | Surgical mask worn for patients with febrile respiratory illness |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Laboratory-confirmed Influenza Infection | Laboratory confirmed influenza | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Physician Visits for Respiratory Illness | visit to primary care MD | one year |
| Influenza-like Illness | Cough and fever | Over entire study period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Loeb, MD, MSc | Hamilton Health Sciences - McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamilton Health Science | Hamilton | Ontario | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19797474 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1. Surgical | surgical mask |
| FG001 | 2. N95 Respirator | N95 respirator |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 1. Surgical | surgical mask |
| BG001 | 2. N95 Respirator | N95 respirator |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Laboratory-confirmed Influenza Infection | Laboratory confirmed influenza | Posted | Number | participants | one year |
|
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mark Loeb | McMaster University | 905-525-9140 | 26066 | loebm@mcmaster.ca |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D000087162 | N95 Respirators |
| ID | Term |
|---|---|
| D058257 | Surgical Attire |
| D004865 | Equipment and Supplies, Hospital |
| D004864 | Equipment and Supplies |
| D012134 | Respiratory Protective Devices |
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| N95 mask |
| Device |
N95 mask worn for patients with febrile respiratory illness |
|
| Absenteeism | Absent from work because of flu-like illness | over study period |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Physician Visits for Respiratory Illness | visit to primary care MD | Posted | Number | participants | one year |
|
|
|
| Secondary | Influenza-like Illness | Cough and fever | Posted | Number | participants | Over entire study period |
|
|
|
| Secondary | Absenteeism | Absent from work because of flu-like illness | Posted | Number | participants | over study period |
|
|
|
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D000067393 | Personal Protective Equipment |
| D011482 | Protective Devices |
| D013523 | Surgical Equipment |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |