Non Invasive Positive Pressure Ventilation to Minimize Aerosolization for COVID 19

NCT ID: NCT04344925

Last Updated: 2021-03-01

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 21 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-04-18
• Study Completion Date: 2020-11-27

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.

Conditions

COVID-19

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Aerosol-reducing Mask

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.

Aerosol-reducing Mask

Intervention Type: DEVICE

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.

Standard Mask

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.

Standard Mask

Intervention Type: DEVICE

Patient will be put on BIPAP using the standard mask

Interventions

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.

Intervention Type: DEVICE

Standard Mask

Patient will be put on BIPAP using the standard mask

Intervention Type: DEVICE

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 <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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

London Health Science Centre

London, Ontario, Canada

Countries

Canada

Other Identifiers

137654

Identifier Type: -

Identifier Source: org_study_id