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 personalised ventilation hood device (the McMonty) to provide a physical barrier to droplet and aerosol spread. The McMonty hood will provide health care workers with protection from droplets and aerosols during routine care and 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) and a ventilation system to reduce aerosol spread from a COVID-19 or other infectious patient. 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 on through a High Efficiency Particulate Air (HEPA) filter, thereafter returning to the hospital ward/ICU (similar to that for a patient’s mechanical ICU ventilator). The entire McMonty personal isolation unit 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 heat (70°C for 10 minutes), and soap/detergent (exposure to soap for 15 minutes). The hood can be thermally disinfected in a standard industrial washing machine (initial studies on the hood prototype have been successful) followed by drying. The remainder (frame, hoops) of the McMonty hood can be readily cleaned down with alcohol wipes. We aim to evaluate the safety of the portable McMonty hood in a clinical setting on use of 20 patients.
Interventions
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 o
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.
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
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.
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.
Outcome results
None listed