Non Invasive Positive Pressure Ventilation to Minimize Aerosolization for COVID 19

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

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.

Study Overview

• Status: Terminated
• Conditions: COVID-19
• Intervention / Treatment: Device: Aerosol-reducing Mask; Device: Standard Mask

• Study Type: Observational
• Enrollment (Actual): 21

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A5W9
      • London Health Science Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult patients presenting to the emergency department with respiratory distress requiring non-invasive ventilation.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: 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.
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.	Device: Standard Mask; Patient will be put on BIPAP using the standard mask

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2020
• Primary Completion (Actual): November 27, 2020
• Study Completion (Actual): November 27, 2020

Study Registration Dates

• First Submitted: April 3, 2020
• First Submitted That Met QC Criteria: April 9, 2020
• First Posted (Actual): April 14, 2020

Study Record Updates

• Last Update Posted (Actual): March 1, 2021
• Last Update Submitted That Met QC Criteria: February 25, 2021
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 137654

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No