None listed
Conditions
Brief summary
We are currently facing a global pandemic of COVID-19, caused by the novel coronavirus, SARS-CoV-2. Frontline healthcare workers, especially anaesthetic staff, are particularly vulnerable because of frequent performance of aerosolized-generated procedures, such as bag-mask ventilation and intubation. N95 filtering facepieces are recommended for use by healthcare workers who come into contact with airborne or aerosolized infectious diseases. The protection that is provided by these devices is dependent on the filter’s efficiency and seal quality. According to the recommendations by Standards Australian (AS/NZS 1715-2009), healthcare workers should undergo regular fit testing. Australian Guidelines for the Prevention and Control of Infection in Healthcare (2019) recognises that fit testing is a valuable practice, which provides an opportunity to educate healthcare professionals. There are two types of N95 mask examinations — fit check and fit test. Fit checks, also known as the user seal checks, are fast and simple. It is performed by the wearer, who detects if a gross leak is present. Quantitative fit tests are more objective but require the use of specialised equipment by a trained operator. We would like to compare the fit testing results between the two types of N95 masks, namely the Halyard* N95 Particulate Filter Respirators and the ProShield® N-95 masks. There has been no published literature on the performance of these two types of masks. We would also like to compare the fit check with the fit testing results.
Interventions
We will perform a user seal check and a quantitative fit testing of N95 masks on a total of 80 of the anaesthetic staff members. Before the commencement of the study, all participants will have received a formal personal protective equipment (PPE) training session, which includes N95 masks donning/doffing technique and user seal check method. They will also watch a video demonstration on fit testing procedure.
Two types of N95 masks are selected for this project: 1) Halyard N95 Particulate Fil
We will perform a user seal check and a quantitative fit testing of N95 masks on a total of 80 of the anaesthetic staff members. Before the commencement of the study, all participants will have received a formal personal protective equipment (PPE) training session, which includes N95 masks donning/doffing technique and user seal check method. They will also watch a video demonstration on fit testing procedure. Two types of N95 masks are selected for this project: 1) Halyard N95 Particulate Filter Respirators, and 2) ProShield® N-95 masks. Each participant will fit check and fit test both brands of the masks. The order of the N95 mask brand to be examined is randomly allocated. The participant will don the first probed and randomised mask, and perform a user seal check in front of a mirror. A negative result means the wearer could not detect any gross leakage and will then proceed to the quantitative fit test with that mask. The quantitative fit test involves the use of the Portacount machine, which will be calibrated at the beginning of each testing day, using a provided HEPA filter. The subject will attach their mask probe to the PortaCount machine via plastic tubing that has been soaked in 99.5% isopropyl alcohol solution. The test will then begin according to the United States Occupational Safety and Health Administration protocols (https://www.osha.gov/laws-regs/federalregister/2019-09-26), which consists of 4 exercises: 1) Bending over at the hips and returning to upright repeatedly, taking two breaths when bent over. This lasts 50 seconds. 2) Reading a standardized text aloud for 30 seconds 3) Moving the head from side to side for 30 seconds 4) Flexing and extending the neck for 39 seconds The test will be observed throughout by personnel trained in the use of the PortaCount machine and any breach of protocol will be addressed by recommencing the test. At the conclusion of the test the subject will then disconnect and doff the mask. The participant will then go through the same user seal check and quantitative fit tests as described above with the second brand of the N95 mask. The user seal check result and the fit factor for both brands of the N95 masks will be recorded.
Sponsors
The Royal Melbourne Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Anaesthetic staff members, including anaesthetic consultants and trainees who is currently working in the Royal Melbourne Hospital
Exclusion criteria
Currently experiencing respiratory symptoms or Have facial beard
Outcome results
None listed