Non Invasive Positive Pressure Ventilation to Minimize Aerosolization for COVID 19

Lawson Health Research Institute

Status: Terminated

Conditions: COVID-19

Treatments: Device: Aerosol-reducing Mask; Device: Standard Mask

Study type: Observational

Funder types: Other

Identifiers

NCT04344925

137654

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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 <18 years.
• Respiratory failure due to non-pulmonary pathology.
• Impaired consciousness (Glasgow coma scale <10).
• Patients with contraindications of NIV.
• Severe upper gastrointestinal bleeding.
• Chest trauma.
• Agitated or violent patient.

Trial design

21 participants in 2 patient groups

Aerosol-reducing Mask

Description:

The participant will be placed 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.

Treatment:

Device: Aerosol-reducing Mask

Standard Mask

Description:

The patient will be placed on BIPAP using the standard 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.

Treatment:

Device: Standard Mask