Non Invasive Positive Pressure Ventilation to Minimize Aerosolization for COVID 19

NCT04344925 | Terminated DMC

• 1 other identifier: 137654
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Glasgow Coma Scale(GCS)

  Baseline to 24 hours

• Respiratory Rate

  Baseline to 24 hours

• Heart Rate

  Baseline to 24 hours

• Metabolic Data: Blood Gas Measurements

  Baseline to 24 hours

• Metabolic Data: Bicarbonate (HC03)

  Baseline to 24 hours

Study Arms (2)

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

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

Interventions

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.

Aerosol-reducing Mask

Standard Mask DEVICE

Patient will be put on BIPAP using the standard mask

Standard Mask

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Patient with respiratory failure due to primary pulmonary pathology.
• Patient who is selected for BiPAP or CPAP by the health care provider

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

London Health Science Centre

London, Ontario, N6A5W9, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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).

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: April 14, 2020
• Study Start: April 18, 2020
• Primary Completion: November 27, 2020
• Study Completion: November 27, 2020
• Last Updated: March 1, 2021

Record last verified: 2020-06

Locations

CA (1)