Official Title
Non-invasive Positive Pressure Ventilation Mask to Minimize Mask Leak and Potential Aerosolization Leading to Spread of Virus Such as COVID-19: A Non-inferiority Trial
Brief Summary

Patients presenting to the emergency department, or needing hospitalization, for a variety of medical conditions often require non-invasive ventilation (breathing support). For example, for a person with shortness of breath as a complication of COPD (Chronic obstructive pulmonary disease) the gold standard of care requires application of a BiPAP machine. However, in the current environment of COVID-19, the aerosols produced by this machine in a COVID-19 positive patient pose serious potential harms to healthcare providers and other patients. All patients with similar symptoms to COVID-19 need to be treated as positive until definite testing determines otherwise. The best test available for COVID-19 takes up to 4 hours to determine the patients status, which is too long to delay application of a BiPAP. This could lead to either a delay in care or the need for invasive breathing measures (intubation), which requires intense resource utilization, may not be in line with a patient's goals of care, and could cause serious harms (i.e. infection, medication reactions, etc.) in patients who do not need it. The use of a closed-loop BiPAP machine in which no expired air is released into the environment would solve these problems. Building off the failures of a similar approach that was trialed in Italy in response to the COVID-19 crisis, this project will develop and test a novel closed-loop BiPAP system.


Device: Aerosol-reducing Mask
Patient will be put on BIPAP using the aerosol-reducing mask. In the case where the patient is located in a care area where BIPAP is prohibited with a standard mask, they will assigned the aerosol-reducing mask.
Aerosol-reducing Mask

Device: Standard Mask
Patient will be put on BIPAP using the standard mask
Standard Mask

Eligibility Criteria

Inclusion Criteria: - Patient with respiratory failure due to primary pulmonary pathology. - Patient who is selected for BiPAP or CPAP by the health care provider

Exclusion Criteria: - Age

Eligibility Gender
Eligibility Age
Minimum: 18 Years

Tarek Loubani, MD

Chelsea Darling

Lawson Health Research Institute
NCT Number