Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000472976p
Ethics application status
Submitted, not yet approved
Date submitted
7/04/2020
Date registered
15/04/2020
Date last updated
15/04/2020
Date data sharing statement initially provided
15/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
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.
Scientific title
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.
Secondary ID [1] 300961 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 316980 0
Respiratory failure. 316981 0
Safe inter- and intra- hospital transfer of patients suffering from suspected or confirmed COVID-19 316982 0
Condition category
Condition code
Infection 315145 315145 0 0
Other infectious diseases
Respiratory 315146 315146 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 317282 0
Treatment: Devices
Comparator / control treatment
None.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323413 0
Patient comfort and tolerability as assessed by a 6 point question item originally developed for CPAP use. We will use a modified version of the 6 point scale developed by Balachandran et al JCSM 2013. It is a 6 point Likert scale.
Timepoint [1] 323413 0
At 24 hours after initiation of therapy and every subsequent 24 hours of use of the mask until disposition from hospital.
Secondary outcome [1] 381865 0
Usage or compliance as assessed by time on the mask as assessed from the hospital electronic medical record.
Timepoint [1] 381865 0
At disposition from hospital

Eligibility
Key inclusion criteria
Consecutive patients admitted to Monash Health with suspected or confirmed COVID-19
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients shown to have proven COVID-19 swab negative.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
NA
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Consecutive patients admitted to Monash Health with suspected or confirmed COVID-19
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is a descriptive study of the comfort and tolerability of a non-TGA approved mask thought to provide a better safety profile than current clinical setup for the treatment of patients with suspected or confirmed COVID-19.
We will describe the comfort (ordinal scale) tolerability (time, continuous variable).
For the ordinal comfort scale we will describe at the group level and include within group and between group comparisons depending on admission location (ward vs high dependency unit) and treatment administration (oxygen vs air pressure).
For comparisons of ordinal data between group comparisons will be made via Mann-Whitney and within group comparisons with Wilcoxon sign rank test.
For comparisons of continuous data t-test (or non-parametric equivalent) will be used.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/04/2020
Actual
Date of last participant enrolment
Anticipated
13/10/2020
Actual
Date of last data collection
Anticipated
27/10/2020
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 16399 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 29944 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 305407 0
Hospital
Name [1] 305407 0
Monash Health
Country [1] 305407 0
Australia
Primary sponsor type
Individual
Name
Dr Simon Joosten
Address
Monash Health, Monash Lung and Sleep
246 Clayton Rd
Clayton 3168
Victoria
Country
Australia
Secondary sponsor category [1] 305790 0
None
Name [1] 305790 0
Address [1] 305790 0
Country [1] 305790 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 305729 0
Monash Health
Ethics committee address [1] 305729 0
246 Clayton Rd
Clayton 3168
Victoria
Ethics committee country [1] 305729 0
Australia
Date submitted for ethics approval [1] 305729 0
07/04/2020
Approval date [1] 305729 0
Ethics approval number [1] 305729 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101382 0
Dr Simon Joosten
Address 101382 0
Monash Health
246 Clayton Rd
Clayton 3168
Victoria
Country 101382 0
Australia
Phone 101382 0
+61 3 95942900
Fax 101382 0
+61 3 95946311
Email 101382 0
[email protected]
Contact person for public queries
Name 101383 0
Dr Simon Joosten
Address 101383 0
Monash Health
246 Clayton Rd
Clayton 3168
Victoria
Country 101383 0
Australia
Phone 101383 0
+61 3 95942900
Fax 101383 0
+61 3 95946311
Email 101383 0
[email protected]
Contact person for scientific queries
Name 101384 0
Dr Simon Joosten
Address 101384 0
Monash Health
246 Clayton Rd
Clayton 3168
Victoria
Country 101384 0
Australia
Phone 101384 0
+61 3 95942900
Fax 101384 0
+61 3 95946311
Email 101384 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.