Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000685718p
Ethics application status
Submitted, not yet approved
Date submitted
29/04/2022
Date registered
11/05/2022
Date last updated
11/10/2022
Date data sharing statement initially provided
11/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility study for aerosol containment device for patient transport and ward based care of COVID-19
Scientific title
Feasibility study for aerosol containment device for patient transport and ward based care of COVID-19
Secondary ID [1] 307028 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 326169 0
Influenza 326170 0
Tuberculosis 326171 0
Condition category
Condition code
Infection 323478 323478 0 0
Other infectious diseases
Respiratory 323479 323479 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is an aerosol containment device placed over the head of a patient's hospital bed either during transport between wards in a hospital environment or during care on the ward. It is approximately 1.5m high and 1.5m in length. Made of transparent plastic and does not seal completely around the patient but is open at the front. The intervention will be assembled and applied by hospital staff.
Importantly, the device is not designed to directly change the course of the patient's illness but rather to prevent or reduce the risk that the patient spreads their illness to other patients, staff or visitors to the hospital.
The device will either be applied for transfer between hospital locations (eg. emergency department and ward) or on the ward for a 24hr period.
Adherence and fidelity will be recorded as part of a custom designed survey that will be administered at the time of device usage.
Intervention code [1] 323477 0
Prevention
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331219 0
Successful assembly and application of the device to the patient bed for the purpose of transport or for set duration on hospital ward.

Data will be collected using a custom designed survey administered to trial participants at the time of device use.
Timepoint [1] 331219 0
From intended application of device to intended removal of device (anticipated to be less than 24hrs in all instances)
Secondary outcome [1] 409225 0
Time taken to assemble device will be collected as part of a custom designed survey for this study.
Timepoint [1] 409225 0
At initiation of device use
Secondary outcome [2] 409226 0
Ease of use of the device during transfer and performing observations will be collected as part of a custom designed survey for this study.
Timepoint [2] 409226 0
Within 24hrs of device application
Secondary outcome [3] 409227 0
Perception of safety from aerosol transmission from the patient will be collected as part of a custom designed survey for this study.
Timepoint [3] 409227 0
During device use (within 24hrs of application of device)
Secondary outcome [4] 409228 0
Patient time spent inside aerosol containment device will be collected as part of a custom designed survey for this study.
Timepoint [4] 409228 0
From application to removal of device
Secondary outcome [5] 409229 0
Perceived comfort during time that device is applied will be collected as part of a custom designed survey for this study.
Timepoint [5] 409229 0
From application of device to removal of device

Eligibility
Key inclusion criteria
Consecutive patients admitted to the emergency department or ward with suspected or confirmed COVID-19, influenza or tuberculosis.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to provide consent.
Age less than 18 years.
Inability to communicate in English as determined by the lead investigator at the time of consent.

Study design
Purpose of the study
Prevention
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
This is a feasibility trial of a novel device designed to contain aerosol emissions of patients with infectious respiratory diseases.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
We will use descriptive statistics of administered questionnaires. In particular we are collecting Likert scale ratings of ease of use, perceived safety and comfort of applying the device.
As no control arm is being initiated the statistical analysis for this study will be descriptive/qualitative in nature.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/07/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 37452 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 311340 0
University
Name [1] 311340 0
Monash University
Country [1] 311340 0
Australia
Primary sponsor type
University
Name
Monash Partners
Address
Wellington Rd
Clayton 3800
Victoria
Australia
Country
Australia
Secondary sponsor category [1] 312717 0
Hospital
Name [1] 312717 0
Epworth Health
Address [1] 312717 0
89 Bridge Rd
Richmond 3121
Victoria
Australia
Country [1] 312717 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 310836 0
Monash Health HREC
Ethics committee address [1] 310836 0
Level 2, i Block,
Monash Medical Centre
246 Clayton Road
CLAYTON 3168
Victoria
Australia
Ethics committee country [1] 310836 0
Australia
Date submitted for ethics approval [1] 310836 0
19/04/2022
Approval date [1] 310836 0
Ethics approval number [1] 310836 0

Summary
Brief summary
Our team has developed a device to reduce the risk that patients suffering from infectious airborne diseases such as COVID-19, influenza and tuberculosis can transmit these diseases in hospital settings to staff, visitors and other patients. The device is, deployed over the patient bed and can be attached to an air purifier. There is no hospital grade device registered by the TGA currently available that provides these specifications. This gap in medical device provision has necessitated this improvised solution. This study aims to deploy the laboratory tested equipment in a controlled hospital environment to test feasibility of use.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119038 0
Dr Simon Joosten
Address 119038 0
Monash Lung Sleep Allergy Immunology
Monash Health
Level 2
246 Clayton Rd
Clayton 3168
Victoria
Australia
Country 119038 0
Australia
Phone 119038 0
+61 3 95946666
Fax 119038 0
+61 3 95946310
Email 119038 0
drjoosten@hotmail.com
Contact person for public queries
Name 119039 0
Dr Simon Joosten
Address 119039 0
Monash Lung Sleep Allergy Immunology
Monash Health
Level 2
246 Clayton Rd
Clayton 3168
Victoria
Australia
Country 119039 0
Australia
Phone 119039 0
+61 3 95946666
Fax 119039 0
+61 3 95946310
Email 119039 0
drjoosten@hotmail.com
Contact person for scientific queries
Name 119040 0
Dr Simon Joosten
Address 119040 0
Monash Lung Sleep Allergy Immunology
Monash Health
Level 2
246 Clayton Rd
Clayton 3168
Victoria
Australia
Country 119040 0
Australia
Phone 119040 0
+61 3 95946666
Fax 119040 0
+61 3 95946310
Email 119040 0
drjoosten@hotmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual data will not be made available.
Data will be analysed at a qualitative level from a group perspective.


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.