Non Invasive Positive Pressure Ventilation to Minimize Aerosolization for COVID 19

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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COVID-19

Intervention / Treatment
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* Device: Aerosol-reducing Mask
* Device: Standard Mask


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Aerosol-reducing Mask<br>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. | Device: Aerosol-reducing Mask<br>* 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.<br>|
| Standard Mask<br>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. | Device: Standard Mask<br>* Patient will be put on BIPAP using the standard mask<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Leak Volume of Non Invasive Ventilation Mask | The primary objective of this study is to assess if the mask device leaks when attached to a patient's face in real-world use. This outcome will be measured by having a researcher assess the physical seal on the patient four times throughout the device's use. The researcher will also screen the non-invasive ventilator machine for indications that the leak alarm has been triggered throughout the participant's engagement in the study. This outcome will be measured by total leak volume litres/minute. | Baseline to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glasgow Coma Scale(GCS) | Metabolic data will include measuring the patients level of consciousness through the 15 point Glasgow coma scale (3-15 points, 3 points= lowest level of consciousness (no response, decompensation of patient), 15= awake, oriented, responding appropriately). | Baseline to 24 hours | 
| Respiratory Rate | Respiratory status will be measured in part by the patients respiratory rate by respirations per minute. Normal respiratory rate is 12-20 respirations per minute. | Baseline to 24 hours | 
| Heart Rate | Patient's condition will be measured by vital signs including heart rate in beats per minute. Normal heart rate is 60-100 beats per minute. | Baseline to 24 hours | 
| Metabolic Data: Blood Gas Measurements | The patients pH will be measured to monitor patient condition throughout the study. Normal pH 7.35-7.45. Increasing acidosis indicative of worsening hypercapnia. | Baseline to 24 hours | 
| Metabolic Data: Bicarbonate (HC03) | The patients HC03 level will be measured in mmol/L to monitor patients condition throughout the study. | Baseline to 24 hours | 
| Metabolic Data: Partial Pressure of Carbon Dioxide (PaC02) | The patients PaC02 level will be measured in mmHg to monitor patients condition. throughout the study. Increase in PaC02 levels indicative of worsening hypercapnia. | Baseline to 24 hours | 
| Metabolic Data: Partial Pressure of Oxygen (Pa02) | The patients Pa02 level will be measured in mmHg to monitor patients condition throughout the study. | Baseline to 24 hours |