Influenza
Conditions
Keywords
N95, Respirator, mask, influenza, efficacy
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.
Interventions
DEVICEN95 mask
N95 mask worn for patients with febrile respiratory illness
DEVICESurgical mask
Surgical mask worn for patients with febrile respiratory illness
Sponsors
Health Canada
McMaster University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Laboratory-confirmed Influenza Infection | one year | Laboratory confirmed influenza |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physician Visits for Respiratory Illness | one year | visit to primary care MD |
| Influenza-like Illness | Over entire study period | Cough and fever |
| Absenteeism | over study period | Absent from work because of flu-like illness |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 1. Surgical surgical mask | 225 |
| 2. N95 Respirator N95 respirator | 221 |
| Total | 446 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 4 |
| Overall Study | Withdrawal by Subject | 9 | 7 |
Baseline characteristics
| Characteristic | 2. N95 Respirator | 1. Surgical | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 221 Participants | 225 Participants | 446 Participants |
| Age, Continuous | 35.8 years STANDARD_DEVIATION 10.6 | 36.5 years STANDARD_DEVIATION 10.6 | 36.2 years STANDARD_DEVIATION 10.6 |
| Region of Enrollment Canada | 221 participants | 225 participants | 446 participants |
| Sex: Female, Male Female | 208 Participants | 212 Participants | 420 Participants |
| Sex: Female, Male Male | 13 Participants | 13 Participants | 26 Participants |
Outcome results
Primary
Laboratory-confirmed Influenza Infection
Laboratory confirmed influenza
Time frame: one year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1. Surgical | Laboratory-confirmed Influenza Infection | 50 participants |
| 2. N95 Respirator | Laboratory-confirmed Influenza Infection | 48 participants |
Secondary
Absenteeism
Absent from work because of flu-like illness
Time frame: over study period
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1. Surgical | Absenteeism | 42 participants |
| 2. N95 Respirator | Absenteeism | 39 participants |
Secondary
Influenza-like Illness
Cough and fever
Time frame: Over entire study period
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1. Surgical | Influenza-like Illness | 9 participants |
| 2. N95 Respirator | Influenza-like Illness | 2 participants |
Secondary
Physician Visits for Respiratory Illness
visit to primary care MD
Time frame: one year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1. Surgical | Physician Visits for Respiratory Illness | 13 participants |
| 2. N95 Respirator | Physician Visits for Respiratory Illness | 13 participants |