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Adapting the Decathlon Group Easybreathe® snorkelling face mask for the safer administration of oxygen and/or continuous positive airway pressure and in the intra/interhospital transportation of patients with proven or suspected COVID 19 infection.

Adapting the Decathlon Group Easybreathe® snorkelling face mask for the safer administration of oxygen and/or continuous positive airway pressure and in the intra/interhospital transportation of patients with proven or suspected COVID 19 infection.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620000472976
Enrollment
100
Registered
2020-04-15
Start date
2020-04-27
Completion date
2020-10-13
Last updated
2020-04-20

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

Conditions

None listed

Brief summary

Covid 19 disease, caused by the SARS COV2 virus, is highly infectious. Patients presenting to hospital suspected or proven to have this condition may be at risk of spreading the virus to visitors and staff. The Decathlon BreatheEasy snorkel mask has been adapted to both cover your face and, if required administer O2 or air pressure. This mask has been tested in a laboratory setting at Monash University to demonstrate its safety and it demonstrates a very low level of leakage. We believe the use of this mask on patients with suspected or confirmed Covid 19 disease may reduce the likelihood of transmission of Covid 19 disease to hospital workers and other patients. Currently there is no medical grade device designed to perform these tasks and consequently a non-medical device has been adapted. We aim to test comfort, tolerability adherence to usage of this mask in the clinical setting to determine its feasibility for more widespread use. This will help us to determine if this mask or a subsequent purpose build version with similar specifications will be able to be deployed in hospital settings on a larger scale.

Interventions

We are testing the feasibility and comfort of the use of a novel mask (the Decathlon group EasyBreathe snorkel mask) for the transport of patients between locations at our health service. The Decathlon mask is a non-TGA approved device used for recreational snorkelling. It has been adapted for use in COVID-19 patients by Italian engineers (see https://www.isinnova.it/easy-covid19-eng/) In this trial we propose to apply the Decathlon mask in place of standard delivery systems for oxygen and posi

We are testing the feasibility and comfort of the use of a novel mask (the Decathlon group EasyBreathe snorkel mask) for the transport of patients between locations at our health service. The Decathlon mask is a non-TGA approved device used for recreational snorkelling. It has been adapted for use in COVID-19 patients by Italian engineers (see https://www.isinnova.it/easy-covid19-eng/) In this trial we propose to apply the Decathlon mask in place of standard delivery systems for oxygen and positive airway pressure. The Decathlon mask will be applied by clinicians in the hospital setting. The mask is worn over the entire face and has advantages over conventional delivery methods in that it is thought to reduce the risk of virus aerosolization (a common problem with conventional delivery systems) and therefore increase safety for healthcare workers and other patients at the hospital. We will test mask comfort and tolerability with daily questionnaires. The mask will be applied to suspected or confirmed COVID-19 patients during transfer between the emergency department and other locations such as radiology department, ward and high dependency unit. We anticipate the mask will be worn for several hours at a time depending on patient tolerability (early data from overseas suggests superior tolerability to conventional mask setups). The mask may be used intermittently for the entire patient admission to hospital pending the clinical needs and preference of the patient. We anticipate, based on how conventional treatments are applied, that the patient will use the mask in 3 hour sessions with potential breaks in between to be determined by clinical need and patient tolerability.

Sponsors

Dr Simon Joosten
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

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

Inclusion criteria

Consecutive patients admitted to Monash Health with suspected or confirmed COVID-19

Exclusion criteria

Patients shown to have proven COVID-19 swab negative.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026