Efficacy of face masks against H1N1 swine influenza

A randomised clinical trial of respirators and surgical masks in the prevention of H1N109 and respiratory pathogen infection in Chinese healthcare workers

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000778280

Enrollment

1669

Registered

2009-09-08

Start date

2009-12-01

Completion date

2009-12-14

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

A prospective, three-armed cluster randomized trial of respirator/mask use in frontline health care workers (HCWs) to determine the efficacy of two different kinds of respirators/face masks (N95’s, and surgical masks) during the influenza season on the transmission of pandemic H1N1 09, seasonal influenza and other respiratory viruses. Other respiratory viruses such as respiratory syncytial virus (RSV), adenovirus, parainfluenza viruses, coronaviruses, human metapneumovirus (hMPV), rhinoviruses etc are also associated with outbreaks of acute respiratory disease. Health care workers (HCWs) from the emergency departments, respiratory wards and infectious disease wards of major hospitals in Beijing, China will be recruited. These wards are selected because they are a setting in which repeated and multiple exposures to viral respiratory infections are present for staff. Hospitals will be allocated to one of the three study arms. Participants will be provided with one of two types of masks/respirators (depending on the arm to which the hospital they work in has been randomised) to be worn for four weeks when working on the ward. All participants will be followed up for five weeks (the four weeks of wearing the masks and an extra week of non-mask wearing)

Interventions

Arm One: N95 respirator Respirators are personal protective fitted devices that cover the nose and mouths and operate by purifying the air inhaled by the wearer through filtering materials. In this trial, participants will be asked to wear the respirator continuously on every shift (around 8 hours) over the four week period. They are to remove the respirator when: they exit the department/ward or when they enter the tea room for a break.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

Any nurse, doctor or ward clerk who works full time at the hospital

Exclusion criteria

1) Males with beards, long moustaches or long facial hair stubble 2) Clinical staff with a current respiratory illness, rhinitis and/or allergy (Staff who report having a respiratory illness at the time of recruitment will have their participation delayed by two weeks once they have become asymptomatic) 3) Part-time worker

Outcome results