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Device demonstrated to be less effective than the control mask in reducing leak
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aerosol-reducing Mask | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients presenting to the emergency department with respiratory distress requiring non-invasive ventilation.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London Health Science Centre | London | Ontario | N6A5W9 | Canada |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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The secondary objective of the study is to assess markers of ventilation and perfusion in patients with both Type I and Type II respiratory failure, including pH, pCO2, pO2, respiratory rate, heart rate and level of consciousness (via GCS).
These markers will be measured through routine vital signs monitoring (respiratory rate, heart rate and GCS) and an arterial or venous blood gas (pH, pCO2, pO2).
| Standard Mask | Device | Patient will be put on BIPAP using the standard mask |
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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 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |