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Fit testing of N95 filtering facepieces for anaesthetists and nurses treating COVID-19 patients

Fit testing of N95 filtering facepiece for anaesthetist and anaesthesia nurses managing endotracheal intubations in COVID19 patients

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12620000702910
Enrollment
60
Registered
2020-06-26
Start date
2020-06-29
Completion date
Unknown
Last updated
2020-07-06

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

Conditions

None listed

Brief summary

Study purpose: The purpose of this study is to evaluate the failure rate of this N95 FFP in a group of anaesthetists and anaesthesia nurses. At Austin Health, it is standard practice for the anaesthetist and anaesthesia nurse who are performing tracheal intubation on COVID19 patients to wear a N95 filtering facepiece (FFP). This protects the anaesthetist and nurse from small aerosolized particles and large droplets. To work effectively a N95 FFP must create a tight seal with the user’s face. However due to different facial characteristics, a tight seal may not be achieved with the brand of N95 FFP(BSN Medical Australia ProShield® N95 Medium and Small) that Austin Health is mandating. Fit testing is a rigorous process to ensure that the N95 FFP being used has the ability to form a tight seal. This process is mandatory in the USA and UK and is a requirement specified in Australian Standard AS/NZS 1715-2009. The fit testing method complies with the published protocol of OSHA (Occupational Safety and Health Administration, USA). Who is it for? This research involves fit testing for anaesthetists and anaesthesia nurses who are directly involved in performing tracheal intubation on COVID19 patients. This is a small team of highly trained and skilled medical personnel, who are charged with providing this specialised clinical service for all patients at Austin Health who require tracheal intubation. Study details: At a convenient time that does not impact on clinical care commitments; the participant will attend the department for fit testing. As per standard Austin Health guidelines for PPE training, all participants will have already undergone extensive training and education in donning the N95 FFP. Using the BSN Medical ProShield®N95 FFP size that has been assigned to the participant, a fit test will be performed using internationally accepted fit testing protocol. The fit test will be conducted using the TSI Portacount 8038/8048 machine. Participants who do not pass the fit test will be re-educated on how to put on the FFP using the ‘real time’ mode on the TSI Portacount machine. This will allow the user to see how different adjustments to the N95 FFP can affect the seal in real time. The participants who do not pass fit testing will be offered a different sized BSN Medical ProShield®N95 FFP and retested. ' If the participant is unable to be fitted with either of the BSN Medical ProShield®N95 FFP, an alternative FFP or elastometric respirator will be provided. The testing will be conducted in the Department of Anaesthesia. The duration of tetsing will be approximately 15 minutes.

Interventions

At Austin Health, it is standard practice for the anaesthetist and anaesthesia nurse who are performing tracheal intubation on COVID19 patients to wear a N95 filtering facepiece (FFP). This protects the anaesthetist and nurse from small aerosolized particles and large droplets. To work effectively a N95 FFP must create a tight seal with the user’s face. However due to different facial characteristics, a tight seal may not be achieved with the brand of N95 FFP(BSN Medical Australia ProShield® N95

At Austin Health, it is standard practice for the anaesthetist and anaesthesia nurse who are performing tracheal intubation on COVID19 patients to wear a N95 filtering facepiece (FFP). This protects the anaesthetist and nurse from small aerosolized particles and large droplets. To work effectively a N95 FFP must create a tight seal with the user’s face. However due to different facial characteristics, a tight seal may not be achieved with the brand of N95 FFP(BSN Medical Australia ProShield® N95 Medium and Small) that Austin Health is mandating. Fit testing is a rigorous process performed by anaesthetist to ensure that the N95 FFP being used has the ability to form a tight seal. This process is mandatory in the USA and UK and is a requirement specified in Australian Standard AS/NZS 1715-2009. The fit testing method complies with the published protocol of OSHA (Occupational Safety and Health Administration, USA). As part of clinical governance, the Department of Anaesthesia is undertaking an observational study to evaluate fit testing for anaesthetists and anaesthesia nurses who are directly involved in performing tracheal intubation on COVID19 patients. The fit testing be undertaken with a Portacount Respirator Fit Testing unit. This will ascertain whether the N95 FFP is safe for this high risk procedure. The primary aim of this study is to evaluate the failure rate of this N95 FFP in a group of anaesthetists and anaesthesia nurses. For those who are unable to be fitted with this brand of N95 FFP, alternative respiratory protective equipment will be provided. Testing requires that the participants places the N95 FFP over their face, in the exact same way as they have been taught to apply the FFP. When the participant is satisfied that there is a tight seal with their face, the mask will be attached via a small plastic tube to the testing device. A strict testing protocol based on the OSHA (Occupational Safety and Health Administration, USA) will be applied. This involved the participant inhaling and exhaling normally, then rotating their heads to the left and right, and then bending forwards and straightening whilst breathing normally. Each participant will be tested once. The duration of the testing is approximately 15 minutes. If an participant fails a test, education will be to ensure the mask is placed correctly by reinforcing the correct technique of mask fitting and subsequent re-testing will be done. A pass or fail will be scored for each test.

Sponsors

Austin Health
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Anaesthetists and anaesthesia nurses who are directly involved in performing tracheal intubation on COVID19 patients. To be included, eligible participants must first pass a fit check to be enrolled into this study, A successful pass for a fitness check requires the absence of a air leak during inhalation and exhalation with a N95 FFP in position over the face.

Exclusion criteria

1.All personnel other than Anaesthetists and anaesthesia nurses who are not directly involved in performing tracheal intubation on COVID19 patients. 2. Anaesthetists and anaesthesia nurses who are directly involved in performing tracheal intubation on COVID19 patients who have been assessed as having a unsuccessful fit check and cannot be enrolled in this study. An unsuccessful fit check implies the presence of an air leak during inhalation and exhalation with a N95 FFP in position over the face.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026