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Trial registered on ANZCTR


Registration number
ACTRN12620000500954p
Ethics application status
Not yet submitted
Date submitted
21/04/2020
Date registered
22/04/2020
Date last updated
22/04/2020
Date data sharing statement initially provided
22/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A reusable personalised ventilation hood: A phase 1 safety study of a new device (McMonty) in patients with suspected or confirmed COVID-19.
Scientific title
A reusable personalised ventilation hood for care of patients with suspected or confirmed COVID-19 in the intensive care, emergency and respiratory healthcare settings: A phase 1 safety study of a new device (McMonty).
Secondary ID [1] 301079 0
Nil known
Universal Trial Number (UTN)
U1111-1250-6657
Trial acronym
McMonty
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infectious respiratory diseases (COVID-19) 317147 0
Condition category
Condition code
Respiratory 315300 315300 0 0
Other respiratory disorders / diseases
Infection 315308 315308 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Phase 1 medical device trial investigating the use of a personalised ventilation hood (McMonty hood device) for use by patients with suspected or proven infectious respiratory diseases (primarily COVID-19 suspected or confirmed patients). This non-invasive device provides a physical barrier to droplet and aerosol spread, as well as utilising a ventilation system to reduce aerosol spread from COVID-19 or other infectious diseases. The hood has a skirt that drapes down the sides of the bed and over the patients waist and does not seal around the patient. The hood relies upon air being drawn up the sides of the bed and from the front near the patient’s legs etc. up to the rear, i.e. away from the healthcare worker who is principally at the front/sides of the patient. The air passes through the fan and on through a High Efficiency Particulate Air (HEPA) filter, thereafter returning to the hospital air environment. The device will be used continuously for 7 days or until the patient has been declared COVID-19 negative, is discharged from hospital, or elects to withdraw from the study. Use of the device is entirely voluntary, and patients may elect to cease use of the device at any time either temporarily, or permanently. Staff will be asked to complete simple data for each clinical shift about device compliance use. In addition, measures to capture technical product adverse events and complaints will be captured by forms available to clinical staff and checked daily by the investigator team. Technical product complaint data will be submitted to an independent data safety monitor team.
Intervention code [1] 317390 0
Prevention
Comparator / control treatment
There is no comparator or control treatment for the device. The alternative to not receiving the device is standard care i.e. care of patient without using device. There will be no data collection of patients receiving standard care.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323544 0
Clinical safety assessment will be performed by collation of technical product complaints forms. The technical product complaint form will capture descriptive information from staff about device malfunction, breakage or incidents related to use of the device. The investigator team will then assess this information and categorise the event against criteria for the following:
Adverse device effect (ADE). Adverse event related to the use of the investigational product.

Adverse event (AE). Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device.

Serious adverse effect (SAE). Any adverse effect that results in any of the following outcomes: death, a life-threatening adverse effect, inpatient hospitalization or prolongation of existing hospitalization, a persistent or injury or permanent impairment to a body structure or a body function.

Unanticipated serious adverse device effect (SADE). Serious adverse device effect which by its nature, incidence, severity or outcome has not been identified in the current version of the risk analysis report.

This report will then be distributed to an independent data safety monitor team for escalation of regulatory reporting as required.
Timepoint [1] 323544 0
Safety assessment data capture can occur at any time throughout clinical use of the device. All staff will be able to submit a technical product complaint form at any time.
Secondary outcome [1] 382192 0
Staff satisfaction of device use. Staff will be invited to complete a questionnaire about their experience of using the device. Questionnaire will ask qualitative questions relating to staff perceived rating of safety, utility features of the device, device interference with patient care, like/dislike of features of device, noise of device, use of the fan, structural integrity, ease of cleaning, use of aerosolizing procedures during patient care, and an overall rating of the device.
Timepoint [1] 382192 0
Questionnaires to be completed voluntarily by clinical staff after caring for the patient using the device. It is anticipated that at least two to three staff members will care for a patient using the device in each 24 hour period.
Secondary outcome [2] 382239 0
Patient satisfaction of device use. The patient will be read a simple statement from the nursing staff, inviting them to answer the questionnaire. Qualitative questions asked are patients perceived feeling of safety within the hood, feeling of claustrophobia, perception of temperature comfort within the hood, noise rating, interference of the hood device on communication with staff.
Timepoint [2] 382239 0
Questionnaire to be completed voluntarily by patients, where the patient is awake, cooperative and able to communicate appropriately. Device will be trialed on 20 patients but not all patients may be able to complete the questionnaire. Where appropriate, invitation to complete the questionnaire will be offered at the end of the 7 day treatment, upon discharge from hospital or when patient elects to withdraw from the study (whichever occurs first).

Eligibility
Key inclusion criteria
Adult patients >18 years, being cared for in the intensive care unit, emergency department and general ward area, who are presumed or confirmed to have COVID-19.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded from being cared for using the McMonty hood for any of the following reasons:
• Less than 18 years of age
• Pregnancy
• Displaying active signs of delirium
• History of dementia
• Patients deemed by healthcare staff to be at risk of injuring themselves or others due to mental illness, behaviour of concern or otherwise
• Patients known to suffer from claustrophobia
Additionally (& importantly), care of the patient using the McMonty Hood can be ceased (either temporarily or permanently) at any time if a patient indicates that they no longer wish to be enclosed by the hood.

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)
Allocation is not concealed
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
The safety questionnaire is of qualitative design. It is not possible to perform a power analysis of the number of patients/staff required to be enrolled to indicate device success. A convenience sample of 20 patients has been determined sufficient for useful qualitative safety data. There is no plan to perform any inferential statistics. Given that each presumed COVID-19 patient will spend 24 hours (3 nursing shifts) in the hospital prior to clearance/confirmation of COVID-19 we suspect that each patient receiving a McMonty hood will generate at least 5 questionnaires, i.e. 100 in total.

There are 18 staff questions to be answered in the questionnaire, and 5 patient questions. All questions shall be ‘worth’ one point. We propose/deem that a 75% favourable response rate (e.g. 15/19 or 4/5) indicates a minimum percentage to declare that the McMonty hood has successfully passed this safety study. That is, a minimum of 75% of completed staff answers to the 18 staff questions needs be answered favourably. Similarly, 75% of completed patient answers to the 5 patient questions are required to be answered favourably. Incomplete answers (no response to Yes/No or scale of 0-10 questions) will be examined for themes of interest (safety, efficacy, mobility, etc.), but not included in the calculations of achieving a 75% favourable response rate. We will also assess responses for answers to open ended questions for such themes of interest. If less than 4 questions are completed the results such a questionnaire will not be included in the study. Since staff are asking patients for their opinions it is probable that most patient questions (5 total) will all be answered.

We will evaluate the success/failure of the trial after 10 patients have been enrolled. If it is calculated that there is a less than 75% favourable response rate to questions the trial will be terminated early and further plans reassessed by the researchers. Further, if there are 3 or more serious adverse events or 5 of more adverse events the study will be terminated early and reassessed.


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2020
Actual
Date of last participant enrolment
Anticipated
1/06/2020
Actual
Date of last data collection
Anticipated
1/06/2020
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 16510 0
Footscray Hospital - Footscray
Recruitment hospital [2] 16511 0
Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 30067 0
3011 - Footscray
Recruitment postcode(s) [2] 30068 0
3021 - St Albans

Funding & Sponsors
Funding source category [1] 305516 0
Charities/Societies/Foundations
Name [1] 305516 0
Western Health Foundation
Country [1] 305516 0
Australia
Funding source category [2] 305519 0
University
Name [2] 305519 0
Melbourne University
Country [2] 305519 0
Australia
Primary sponsor type
Hospital
Name
Western Health
Address
Western Health, 176 Furlong Rd, St Albans, VIC., 3021
Country
Australia
Secondary sponsor category [1] 305925 0
None
Name [1] 305925 0
None
Address [1] 305925 0
None
Country [1] 305925 0
Other collaborator category [1] 281291 0
University
Name [1] 281291 0
Melbourne University
Address [1] 281291 0
Melbourne University, Dept of Mechanical Engineering, Level 4, Engineering Block E Building (170), Grattan Street, Parkville Campus, VIC., 3052
Country [1] 281291 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 305829 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 305829 0
Ethics committee country [1] 305829 0
Australia
Date submitted for ethics approval [1] 305829 0
24/04/2020
Approval date [1] 305829 0
Ethics approval number [1] 305829 0
2020.129

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101738 0
Dr Forbes McGain
Address 101738 0
c/o Footscray Hospital (Western Health), Department of Intensive Care, Level 1, 160 Gordon Street, Footscray, VIC., 3011
Country 101738 0
Australia
Phone 101738 0
+61 3 8345 6639
Fax 101738 0
+61 3 8345 7610
Email 101738 0
forbes.mcgain@wh.org.au
Contact person for public queries
Name 101739 0
Forbes McGain
Address 101739 0
c/o Footscray Hospital (Western Health), Department of Intensive Care, Level 1, 160 Gordon Street, Footscray, VIC., 3011
Country 101739 0
Australia
Phone 101739 0
+61 3 8345 6639
Fax 101739 0
+61 3 8345 7610
Email 101739 0
forbes.mcgain@wh.org.au
Contact person for scientific queries
Name 101740 0
Forbes McGain
Address 101740 0
c/o Footscray Hospital (Western Health), Department of Intensive Care, Level 1, 160 Gordon Street, Footscray, VIC., 3011
Country 101740 0
Australia
Phone 101740 0
+61 3 8345 6639
Fax 101740 0
+61 3 8345 7610
Email 101740 0
forbes.mcgain@wh.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Only aggregate data will be made publicly available.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7688Clinical study report    Yet to be published. The investigator team plan t... [More Details]



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo This study complements our preclinical assessment ... [More Details]
Study results articleYes McGain F, Bates S, Lee JH, Timms P, Kainer MA, Fre... [More Details]

Documents added automatically
No additional documents have been identified.