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Trial registered on ANZCTR


Registration number
ACTRN12620000477921
Ethics application status
Approved
Date submitted
2/04/2020
Date registered
16/04/2020
Date last updated
8/09/2020
Date data sharing statement initially provided
16/04/2020
Date results information initially provided
8/09/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The design of an updated iron lung ventilator which can be easily built and used by people with minimal training in situations such as COVID-19 where skilled doctors or normal ventilators are unavailable.
Scientific title
The use of a simplified negative pressure cuirass style ventilator under COVID-19 pandemic conditions in support of critically overwhelmed healthcare systems
Secondary ID [1] 300932 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ventilation 316913 0
COVID-19 316914 0
Coronavirus 316915 0
Acute Respiratory Distress Syndrome 316916 0
Condition category
Condition code
Respiratory 315088 315088 0 0
Other respiratory disorders / diseases
Emergency medicine 315089 315089 0 0
Resuscitation
Anaesthesiology 315090 315090 0 0
Other anaesthesiology
Infection 315246 315246 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is an unblinded trial of a cuirass based negative pressure ventilator.
The device consists of a plastic casing (cuirass) placed over the thorax with negative pressure of -200cmH2O applied by a household vacuum cleaner.The negative pressure in the cuirass facilitates inspiration. The device cycles back to atmospheric pressure allowing expiration.
Following confirmation of fit by the research team, application of ANZCA standard monitoring (Australian and New Zealand College of Anaesthetists, 2017) and trial of the device in an awake volunteer, the study will use sedation to simulate an unwell patient.
Baseline data before intervention will include AVPU level of consciousness, HR, SpO2 and Vt on room air, then HR and SpO2 on 4L/min via Hudson mask.
The patient will be ventilated using the device with supplemental oxygen via Hudson face mask at 4L/min for one hour. Tidal volumes will be recorded every 15 minutes. The Hudson mask will be removed and a face mask connected to a GE Anaesthetic Machine running FiO2 at 30%, 4L/min will be used to record Vt for 3 consecutive breaths.
Sedation will be provided by an accredited Consultant Anaesthetist and targeted to maintain an AVPU score of ā€˜Vā€™, that is, rousable to command. The level of sedation will be targeted to not require direct airway intervention. Sedation will be provided using propofol and Total Intravenous Anaesthesia (TIVA) using the Marsh algorithm. An initial bolus of Lignocaine will be included with the propofol to minimise patient discomfort as per accepted practice.
An anaesthetic record will be maintained as per ANZCA Guidelines (Australian and New Zealand College of Anaesthetists, 2019).
The trial will be conducted in an operating theatre environment with full resuscitation capabilities including trained assistance and support staff.
Intervention code [1] 317248 0
Treatment: Devices
Comparator / control treatment
Comparison made to baseline observations in the same volunteer.
Control group
Active

Outcomes
Primary outcome [1] 323385 0
Recorded tidal volumes whilst continuously using the pandemic cuirass ventilator for 60 minutes. Tidal volumes will be recorded using a face mask connected to an existing GE Anaesthetic Machine.
Timepoint [1] 323385 0
Tidal volumes will be assessed every 15 minutes. Total sedation time will be 60 minutes.
Secondary outcome [1] 381752 0
Number of times device requires external intervention to maintain fit will be assessed by direct observation of the research team.
Timepoint [1] 381752 0
The ventilator will be assessed from initial fit through to the end of the sedation period.

Eligibility
Key inclusion criteria
1 healthy volunteer, of average age and size.
Minimum age
35 Years
Maximum age
45 Years
Gender
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pre-exisiting medical illness. History of adverse reaction to anaesthetic agent.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Comparison of tidal volumes during intervention will be compared to baseline measures.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Descriptive statistics will be reported comparing baseline to intervention data.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 16341 0
St John of God Hospital, Murdoch - Murdoch
Recruitment postcode(s) [1] 29885 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 305378 0
Hospital
Name [1] 305378 0
Saint John of God Murdoch Hospital
Address [1] 305378 0
100 Murdoch Dr
Murdoch WA 6150
Country [1] 305378 0
Australia
Funding source category [2] 305410 0
Self funded/Unfunded
Name [2] 305410 0
Dr Michael Soares
Address [2] 305410 0
Perth Anaesthetic Group
5/38 Meadowvale Ave
SOUTH PERTH WA 6151
Country [2] 305410 0
Australia
Primary sponsor type
Individual
Name
Dr Michael Soares
Address
Perth Anaesthetic Group
5/38 Meadowvale Ave
SOUTH PERTH, WA
AUSTRALIA 6010
Country
Australia
Secondary sponsor category [1] 305756 0
None
Name [1] 305756 0
Address [1] 305756 0
Country [1] 305756 0
Other collaborator category [1] 281262 0
Individual
Name [1] 281262 0
Mr Benjamin Henry
Address [1] 281262 0
Perth Anaesthetic Group
5/38 Meadowvale Ave
SOUTH PERTH WA 6010
Country [1] 281262 0
Australia
Other collaborator category [2] 281263 0
Individual
Name [2] 281263 0
Mr Michael Pearson
Address [2] 281263 0
Perth Anaesthetic Group
5/38 Meadowvale Ave
SOUTH PERTH WA 6010
Country [2] 281263 0
Australia
Other collaborator category [3] 281264 0
Individual
Name [3] 281264 0
Mr Arthur Manowski
Address [3] 281264 0
Perth Anaesthetic Group
5/38 Meadowvale Ave
SOUTH PERTH WA 6010
Country [3] 281264 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305709 0
Saint John of God Healthcare
Ethics committee address [1] 305709 0
St John of God Health Care Human Research Ethics Committee
C/o St John of God Subiaco Hospital
12 Salvado Road
Subiaco Western Australia 6008
Ethics committee country [1] 305709 0
Australia
Date submitted for ethics approval [1] 305709 0
08/04/2020
Approval date [1] 305709 0
20/04/2020
Ethics approval number [1] 305709 0

Summary
Brief summary
We herein propose a simple, achievable and safe method of assisting ventilation using a high throughput device, which can be operated without specific skills in ventilator management.
The device is a modernised version of the Both Respirator created in 1939.
A Modern commercial version has been FDA approved in the United States by Hayek Medical, but currently lacks Australian distribution.
As advertised by Hayek Medical, a cuirass ventilator does not require skilled medical professionals. Our simplified device has also been designed to not require a skilled
medical professional. Moreso, this device is specifically designed with simplified parts so it can be built quickly and easily in regional areas.
Trial website
Trial related presentations / publications
Public notes
A lack of critical resources such as ICU beds and ventilators is thought to be a key determinant of mortality, and their allocation is requiring doctors to make decisions on patient survival based on perceived merit rather than medical grounds.in other parts of the world.
Regional centres in Australia with populations > 10,000 with 2 operating theatres and at most 5 high dependency beds could potentially have close to 150 ventilation requiring patients per ventilator.
This device of last resort is designed to be safely and easily built and used in areas of greatest need.

Contacts
Principal investigator
Name 101306 0
Dr Michael Soares
Address 101306 0
Perth Anaesthetic Group
5/38 Meadowvale Ave
SOUTH PERTH WA 6010
Country 101306 0
Australia
Phone 101306 0
+61893678311
Fax 101306 0
+61893677197
Email 101306 0
cuirass@periopmed.com.au
Contact person for public queries
Name 101307 0
Dr Michael Soares
Address 101307 0
Perth Anaesthetic Group
5/38 Meadowvale Ave
SOUTH PERtH WA 6010
Country 101307 0
Australia
Phone 101307 0
+61893678311
Fax 101307 0
+61893677197
Email 101307 0
cuirass@periopmed.com.au
Contact person for scientific queries
Name 101308 0
Dr Michael Soares
Address 101308 0
Perth Anaesthetic Group
5/38 Meadowvale Ave
SOUTH PERTH WA 6010
Country 101308 0
Australia
Phone 101308 0
+61893678311
Fax 101308 0
+61893677197
Email 101308 0
cuirass@periopmed.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All data after de-identification
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Case by case basis at the discretion of the Primary Sponsor
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Access subject to approvals by Principal Investigator, cuirass@periopmed.com.au
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 7498 0
Ethical approval
Citation [1] 7498 0
Link [1] 7498 0
Email [1] 7498 0
cuirass@periopmed.com.au
Other [1] 7498 0
Attachment [1] 7498 0
Type [2] 7499 0
Informed consent form
Citation [2] 7499 0
Link [2] 7499 0
Email [2] 7499 0
cuirass@periopmed.com.au
Other [2] 7499 0
Attachment [2] 7499 0
Type [3] 7500 0
Study protocol
Citation [3] 7500 0
Link [3] 7500 0
Email [3] 7500 0
cuirass@periopmed.com.au
Other [3] 7500 0
Attachment [3] 7500 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results ā€“ basic reporting
Results ā€“ plain English summary