Recognising the prolonged periods of time that healthcare workers would be in close contact with COVID-19 patients, the ICU research team at Western Health began proactively examining ways to protect the health of front-line staff, particularly nurses.

Dr Forbes McGain, intensivist and anaesthetist at Western Health, conceptualised the idea of having a personalised ventilation hood – something that will help protect healthcare workers (in addition to wearing personal protective equipment - PPE) from aerosol and droplet spread of infectious patients – particularly COVID-19.

Dr McGain was predominantly concerned about healthcare workers that would be in very close contact for prolonged periods of time; especially nurses caring for these patients. So, he contacted Professor Jason Monty, Head of Department and a Professor with the Fluid Mechanics Group in the Department of Mechanical Engineering at The University of Melbourne, and outlined the scope of what he was looking for—within 48 hours Prof Monty’s team had built a prototype.

The prototype was brought initially into the Footscray Hospital ICU for staff to engage with and see if the device would meet specifications and the clinical need. The team enlisted the expertise of Samantha Bates, Research Manager for The Department Of Intensive Care Anaesthesia, Pain And Perioperative Medicine at Western Health, who was amongst those who road-tested it and she suggested tweaks such as a slight extension away from the patient.

“Over the next couple of weeks and visits also to Sunshine Hospital ICU, they kept tweaking the prototype models and got it to the point where we needed to test it as a clinical trial. That’s where my expertise as a research manager came in – to help draft up the clinical trial protocol.

“Medical device trials can be a lot more cumbersome in terms of the approach to ethics reviews, and to draft that protocol up in a short space of time was pretty exhausting (several hundred hours of work for ethics submission), but it was important. By this stage we were close to the end of the first wave and we thought ‘maybe this might be all for naught,’—how wrong we were! We were perhaps being optimistic.” said Ms Bates.

To prevent cross-infection to other patients and to health care workers, patients with infectious respiratory diseases are usually isolated and cared for in single rooms, preferably rooms that have negative air pressure to prevent airborne spread of disease causing pathogens. However, single negative pressure rooms are quite rare to find—particularly in older, smaller hospitals. They are also very expensive to install (>$100,000 per room in addition to single room costs). In a negative pressure room, the air exchange is approx. 12-15 exchanges per hour. This hood device can achieve  100 air exchanges an hour within the plastic canopy cover. This device proposes an answer to the unmet need of negative pressure rooms.

The hood has a high speed extraction fan that, when switched on, draws airflow up from the front of the hood, into the fan, and down the piping at the back, before exiting through a large H13 class, high efficiency particulate air (HEPA) filter.

“It’s a world-first prototype so people are excited to get involved – particularly the nursing staff. When you really want to put something through its paces, you roll it out to a clinical area and let the staff really engage with it.” said Ms Bates.

Dr McGain conceptualised the device in March 2020, HREC approval was granted in June and the first patient was recruited on 23 June. Since then, the team have recruited over 20 patients across Sunshine and Footscray Hospitals.

Unsuspectingly one of the best places to conduct a COVID-19 clinical trial

The first 3-4 patients enrolled in the clinical trial were suspected COVID patients being treated as such. Then the second wave hit Melbourne and Western Health were smack-bang in the middle of the hotspots—Western Health’s ICUs have now cared for more confirmed COVID-19 patients than anywhere else in Australia.

“We’ve had excess of 60 COVID-19 positive patients that we’ve treated in our ICUs alone. Our hospitals have been at full capacity. We had COVID positive patients spilling out from one ward into another. I can’t describe what that’s been like.”

The team at Western Health trialled four of the prototypes in the beginning—two at Footscray Hospital and two at Sunshine Hospital. Nursing staff under the leadership of Nurse Unit Managers Meghan Read and Alex Angel were incredibly engaged and provided valuable feedback that helped shape device development. Then, recognising the clinical potential, ICU nurses began asking for more devices, particularly as patient numbers began to surge, and Prof Monty’s team at The University of Melbourne quickly assembled more.

Novelty

“The novelty of this hood is in its mobility. It’s actually on wheels – the initial concept started from a whiteboard. It was designed to be mobile for convenience, but also as a safety precaution because if a patient deteriorates, you want to fold it up, push it out of the way and get to them quickly.”

Pre-clinical testing has shown that the hood is just as effective as an N95 face mask in reducing aerosol and droplet spread. The science is there, and the clinical trial is predominantly a safety and effectiveness trial to ascertain if the device is applicable in a clinical setting.

Dr McGain also has an interest in sustainability and environmental impact. The device has been designed with sustainability in mind—it’s all completely reusable including the frame mechanism at the back, the clear Perspex back board, and the plastic covers themselves. The team have engaged in a consultative process with the Western Health Infection Prevention Team and the Head of Infectious Diseases Dr Marion Kainer to ensure cleaning processes are effective and can contribute to minimal environmental impact.

Consumer representation

Early in the process of developing the device, the Western Health team recognised the importance of consumer representation in upcoming clinical trials. ICU Research lead Samantha Bates utilised her networks to identify two former ICU patients who offered valuable insight on overall concept and a voluntary patient questionnaire feedback. The consumer representatives offered insight on their experience of being cared for as ICU patients, and how this particular device would be tolerated by patients.

“Then we submitted everything through the Human Research Ethics Committee (HREC) who had some really insightful questions about the project. Research is not easy, which is particularly true in the middle of a pandemic when everything else has been pushed to the side. We were lucky that ethics committees were prioritising COVID projects, so we’ve had brilliant engagement from that point.”

Expanding the clinical trial

Thanks to the success of the initial clinical trial, the trial is being expanded so the device can be rolled-out to other hospitals across the country. The new sites include Alice Springs Hospital, Mildura Base Hospital, Royal Hobart Hospital, The Royal Melbourne Hospital, Austin Hospital, St Vincent’s Hospital Melbourne, Monash Health, Epworth, Freemasons, Epworth Geelong, Northern Hospital, Bendigo Hospital, and Werribee Mercy. Although some of the states and territories are COVID-19 free, the hood also has potential application for other respiratory diseases including Tuberculosis, which disproportionally affects Indigenous populations.

“The multi-site trial will now benefit from our experience with the first cohort. It’s been an exhilarating journey; we’ve all learned a lot along the way. Now it comes down to ‘is it going to be useful?’ It’s worked really well for us here at Western Health and I’m excited to see it put through its paces.”

COVID-19 rates among healthcare workers are quite high in Australia, and this device could act as a solution to the concerning infection rates. Although the device won’t replace PPE, it will add another layer to protect those who are directly fighting the COVID-19 virus.