Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000553774
Ethics application status
Approved
Date submitted
30/03/2021
Date registered
11/04/2022
Date last updated
11/04/2022
Date data sharing statement initially provided
11/04/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
A mobile and reusable personalised ventilation hood: A phase 1 safety study of a new device in patients with suspected or confirmed COVID-19.
Scientific title
A mobile and reusable personalised ventilation hood for care of patients with suspected or confirmed COVID-19 in the Emergency Department: A phase 1 safety study of a new device
Secondary ID [1] 302381 0
Nil known
Universal Trial Number (UTN)
U1111-1258-7491
Trial acronym
Mini-McMonty
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 319165 0
Tuberculosis 319166 0
Influenza 319167 0
Measles 319168 0
Condition category
Condition code
Respiratory 317132 317132 0 0
Other respiratory disorders / diseases
Infection 317133 317133 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A phase 1 medical device trial investigating the use of a personalised ventilation hood (The Mini Isolation Hood) for use by Emergency Department (ED) patients with suspected or proven infectious respiratory diseases (primarily COVID-19 suspected or confirmed patients). The device can also be used for patient transport throughout the hospital (eg. movement of patient from ED to other hospital areas such as radiology, or the ward).

This non-invasive device comprises a large, transparent, retractable hood which has a fan and filter attached, that mounts directly to an ED trolley. The hood provides a physical barrier to droplet spread, and the ventilation system is designed to induce negative-pressure within the hood to reduce aerosol spread of COVID-19 or other infectious diseases. The hood has a skirt that drapes down over patient's sides and waist, but does not seal around the patient. The hood relies upon air being drawn from the sides of the bed and from the front (near the patient’s abdomen) 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 through a High Efficiency Particulate Air (HEPA) filter, thereafter returning to the hospital air environment (much like how a mechanical ventilator scrubs and returns air to the local environment).

The device will be used continuously for the duration of the patient's stay in the Emergency Department (including transport within the hospital). The device will be used until (i) the patient has been declared COVID-19 negative, (ii) the patient is discharged from the ED (to home or to a ward), or (iii) the patient 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. ED nursing staff, medical and allied health staff will be responsible for administering the device (and will receive specific training in its use). The device can be used for a single patient encounter (hours/days), but the framework can be cleaned/disinfected for future patient use. Therefore,components of the device can be used for up to 2 years (or more).

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 regularly by the investigator team. Technical product complaint data will be submitted to an independent data safety monitor team.

Staff training and education will be provided by the clinical research team (Doctor who is an Intensive Care and Anaesthetic consultant, and a dedicated critical care research nurse). In-service education sessions will be in a single session of approx. 40 min duration, consisting of both video training and hands-on training. The training video will be provided for staff to view at any time. This education approach will be conducted approx one-week before trial commencement, and will continue throughout trial recruitment. There are a number of staff to educate in the ED setting and it will take time to complete education, however the device trial roll-out needs to occur rapidly as the device helps reduce aerosol and droplet exposure of COVID-19 virus to both healthcare workers, as well as cross-exposure to other patients presenting to the ED. When staff have completed video training the online portal provides a certificate of training completion. Internal hospital staff training checklists will also be used to verify completion of training attendance/completion.

Compliance monitoring will be difficult in a busy ED setting, but a compliance monitoring worksheet will be provided for staff to complete.
Intervention code [1] 318663 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] 325311 0
Staff satisfaction of device use. Staff will be invited to complete a specifically designed questionnaire about their experience using the device. The 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] 325311 0
Questionnaires to be completed voluntarily by clinical staff after caring for the patient using the device (eg. at end of clinical shift). It is anticipated that one to three staff members will care for each patient that uses the device.
Primary outcome [2] 325312 0
Patient satisfaction of device use. The patient will be read a simple statement from the nursing staff, inviting them to answer the specifically designed questionnaire. Qualitative questions asked relate to the perceived feeling of safety within the hood, feeling of claustrophobia, perception of temperature comfort within the hood, noise rating, and interference of the device on communication with staff.
Timepoint [2] 325312 0
Questionnaire to be completed voluntarily by patients, where the patient is awake, cooperative and able to communicate appropriately. Device will be trialed on at least 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 treatment, upon discharge from the ED (to the ward or home) or when the patient elects to withdraw from the study (whichever occurs first).
Secondary outcome [1] 387473 0
Clinical safety assessment will be performed by collation of technical product complaint 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] 387473 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.

Eligibility
Key inclusion criteria
Inclusion criteria for patients
• Adult patients of at least 18 years, presenting to the ED, who are suspected or a respiratory infection that warrants the use of droplet and/or aerosol precautions.

Inclusion criteria for staff
• Any nursing, medical or allied health staff involved in the provision of care to the patient in this study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• <18 years
• 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 Mini Isolation 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 staff and patient safety questionnaires are 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 at least 20 patients has been determined sufficient for useful qualitative safety data. There is no plan to perform any inferential statistics. Given that each suspected COVID-19 patient will spend up to 24 hours (1-3 nursing shifts) in the Emergency Department, we suspect that each patient receiving a Mini Isolation Hood will generate 3 questionnaires on average, i.e. at least 60 questionnaires in total. If required, recruiting will continue beyond 20 patients until at least 10 patient questionnaires and at least 30 staff questionnaires have been completed.

The staff questionnaire has 18 questions (16 multiple choice, 2 open-ended) to be answered, and the patient questionnaire has 9 questions (7 multiple choice, 2 open-ended) to be answered. Only questionnaires with at least 50% of questions answered will be included. Excluded questionnaires will be examined for themes of interest (safety, efficacy, mobility, etc.). All multiple choice questions shall be ‘worth’ one point. Each questionnaire will be determined to be favourable if at least 50% of the multiple choice questions are answered favourably (ie. 8/16 staff questions, 4/7 patient questions). We propose/deem that a 75% favourable response rate indicates a minimum percentage to declare that the Mini Isolation Hood has successfully passed this safety study. That is, a minimum of 75% of completed staff questionnaires need to have been determined to be favourable. Similarly, 75% of completed patient questionnaires need to have been determined to be favourable. We will also assess responses to open ended questions for the above themes of interest. Since staff are asking patients for their opinions it is probable that most patient questions will be answered.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Other reasons/comments
Other reasons
Clinical research coordinator staff were redeployed to intensive care unit to meet clinical patient surge demand from October 2021 to February 2022. Therefore, in absence of research coordinator staff, the trial conduct could not proceed with this adequate safety and regulatory support. The manufacturer of device has since registered product with the Therapeutic Goods Administration (TGA) and a clinical trial is not required.
Date of first participant enrolment
Anticipated
3/01/2022
Actual
Date of last participant enrolment
Anticipated
28/02/2022
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 17636 0
Footscray Hospital - Footscray
Recruitment hospital [2] 17637 0
Sunshine Hospital - St Albans
Recruitment hospital [3] 19045 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 31382 0
3011 - Footscray
Recruitment postcode(s) [2] 31383 0
3021 - St Albans
Recruitment postcode(s) [3] 33593 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 306809 0
Charities/Societies/Foundations
Name [1] 306809 0
Western Health Foundation
Country [1] 306809 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] 307361 0
None
Name [1] 307361 0
Address [1] 307361 0
Country [1] 307361 0
Other collaborator category [1] 281489 0
University
Name [1] 281489 0
The University of Melbourne
Address [1] 281489 0
Melbourne University, Dept of Mechanical Engineering, Level 4, Engineering Block E Building (170), Grattan Street, Parkville Campus, VIC., 3052
Country [1] 281489 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306964 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 306964 0
Royal Melbourne Hospital, Level 2, South West, 300 Grattan Street, Parkville, Victoria, 3052
Ethics committee country [1] 306964 0
Australia
Date submitted for ethics approval [1] 306964 0
06/01/2021
Approval date [1] 306964 0
21/04/2021
Ethics approval number [1] 306964 0
HREC/69339/MH-2021

Summary
Brief summary
Since December 2019, the coronavirus disease (COVID-19) pandemic has affected millions of people worldwide. Modern hospital negative pressure rooms have high flow rates and negative pressure to prevent the spread of TB, measles etc. Nevertheless, such negative pressure rooms do not prevent droplet spread of the infectious disease to personnel within the room. Western Health and The University of Melbourne conceived and developed a small personalised ventilation hood device (the Mini Isolation Hood) to provide a physical barrier to droplet and aerosol spread. The device is based upon the already extant McMonty personal ventilation hood; the Mini Isolation Hood is significantly smaller, is mobile, and is designed to attach directly to an Emergency Department trauma trolley.

The hood will provide health care workers with protection from droplets and aerosols during routine care, during the administration of specialised oxygen therapies (including high flow oxygen and non-invasive ventilation), and during the conduct of aerosol generating procedures. The hood has a plastic barrier to prevent droplet spread from a COVID-19 or other infectious patient, and a ventilation system to reduce aerosol spread. The hood relies upon air being drawn 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 then a High Efficiency Particulate Air (HEPA) filter, thereafter returning to the local Emergency Department environment (similar to that for a patient’s mechanical ventilator).

The entire Mini Isolation Hood is designed to be reusable in order to ensure security of supply during the COVID-19 pandemic. The SARS CoV-2 virus is susceptible, amongst other disinfection treatments, to bleach (chlorine based, e.g. ‘Actichlor’ one part per thousand= one tablet per litre), quaternary ammonium chloride based wipes (e.g. ‘Clinell’), and soap/detergent (exposure to soap for 15 minutes). We aim to evaluate the safety of the Mini Isolation Hood in a clinical setting on use with 20 Emergency Department patients.
Trial website
Trial related presentations / publications
Public notes
Aspects of the development of the predecessor to this device, the larger McMonty personal ventilation hood, can be viewed through the following link:
https://www.youtube.com/watch?v=McQGJpEIqGk&feature=youtu.be

Pre-clinical testing data from the larger McMonty personal ventilation hood is published:
McGain F, Humphries RS, Lee JH, Schofield R, French C, Keywood MD, Irving L, Kevin K, Patel J, & Monty J. Aerosol generation related to respiratory interventions and the effectiveness of a personal ventilation hood. Crit Care Resusc 2020 [Epub ahead of print]

Prospective clinical trial on use of the larger McMonty personal ventilation hood is published:
McGain F, Bates S, Lee JH, Timms P, Kainer MA, French C & Monty J. A prospective clinical evaluation of a patient isolation hood during the COVID-19 pandemic, Australian
Critical Care, May 2021. https://doi.org/10.1016/j.aucc.2021.05.001

Contacts
Principal investigator
Name 105610 0
Dr Forbes McGain
Address 105610 0
c/o Footscray Hospital (Western Health), Department of Intensive Care, Level 1, 160 Gordon Street, Footscray, VIC., 3011
Country 105610 0
Australia
Phone 105610 0
+61 400 224 318
Fax 105610 0
+61 3 8345 7610
Email 105610 0
[email protected]
Contact person for public queries
Name 105611 0
Dr Forbes McGain
Address 105611 0
c/o Footscray Hospital (Western Health), Department of Intensive Care, Level 1, 160 Gordon Street, Footscray, VIC., 3011
Country 105611 0
Australia
Phone 105611 0
+61 3 8345 6639
Fax 105611 0
+61 3 8345 7610
Email 105611 0
[email protected]
Contact person for scientific queries
Name 105612 0
Dr Forbes McGain
Address 105612 0
c/o Footscray Hospital (Western Health), Department of Intensive Care, Level 1, 160 Gordon Street, Footscray, VIC., 3011
Country 105612 0
Australia
Phone 105612 0
+61 3 8345 6639
Fax 105612 0
+61 3 8345 7610
Email 105612 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
Only aggregate data will be made publicly available.


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.