Clinical trial NCT04344925: Non Invasive Positive Pressure Ventilation to Minimize Aerosolization for COVID 19
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: COVID-19
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2020-04-14
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients presenting to the emergency department with respiratory distress requiring non-invasive ventilation.

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.


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.

Primary outcomes:
measure: Total Leak Volume of Non Invasive Ventilation Mask
timeFrame: Baseline to 24 hours
Secondary outcomes:
measure: Glasgow Coma Scale(GCS)
timeFrame: Baseline to 24 hours
measure: Respiratory Rate
timeFrame: Baseline to 24 hours
measure: Heart Rate
timeFrame: Baseline to 24 hours
measure: Metabolic Data: Blood Gas Measurements
timeFrame: Baseline to 24 hours
measure: Metabolic Data: Bicarbonate (HC03)
timeFrame: Baseline to 24 hours
measure: Metabolic Data: Partial Pressure of Carbon Dioxide (PaC02)
timeFrame: Baseline to 24 hours
measure: Metabolic Data: Partial Pressure of Oxygen (Pa02)
timeFrame: Baseline to 24 hours
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Science Centre
state: Ontario
Study officials:
References: