None listed
Conditions
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.
Interventions
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, retr
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.
Sponsors
Western Health
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed