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Non Invasive Positive Pressure Ventilation to Minimize Aerosolization for COVID 19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04344925
Recruitment Status : Terminated (Device demonstrated to be less effective than the control mask in reducing leak)
First Posted : April 14, 2020
Last Update Posted : March 1, 2021
Sponsor:
Information provided by (Responsible Party):
Lawson Health Research Institute

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.

Condition or disease Intervention/treatment
COVID-19 Device: Aerosol-reducing Mask Device: Standard Mask

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Study Type : Observational
Actual Enrollment : 21 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : April 18, 2020
Actual Primary Completion Date : November 27, 2020
Actual Study Completion Date : November 27, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Total Leak Volume of Non Invasive Ventilation Mask [ Time Frame: Baseline to 24 hours ]

    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.



Secondary Outcome Measures :
  1. Glasgow Coma Scale(GCS) [ Time Frame: Baseline to 24 hours ]
    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).

  2. Respiratory Rate [ Time Frame: Baseline to 24 hours ]
    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.

  3. Heart Rate [ Time Frame: Baseline to 24 hours ]
    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.

  4. Metabolic Data: Blood Gas Measurements [ Time Frame: Baseline to 24 hours ]
    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.

  5. Metabolic Data: Bicarbonate (HC03) [ Time Frame: Baseline to 24 hours ]
    The patients HC03 level will be measured in mmol/L to monitor patients condition throughout the study.

  6. Metabolic Data: Partial Pressure of Carbon Dioxide (PaC02) [ Time Frame: Baseline to 24 hours ]
    The patients PaC02 level will be measured in mmHg to monitor patients condition. throughout the study. Increase in PaC02 levels indicative of worsening hypercapnia.

  7. Metabolic Data: Partial Pressure of Oxygen (Pa02) [ Time Frame: Baseline to 24 hours ]
    The patients Pa02 level will be measured in mmHg to monitor patients condition throughout the study.


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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Adult patients presenting to the emergency department with respiratory distress requiring non-invasive ventilation.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04344925


Locations
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Canada, Ontario
London Health Science Centre
London, Ontario, Canada, N6A5W9
Sponsors and Collaborators
Lawson Health Research Institute
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Responsible Party: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT04344925    
Other Study ID Numbers: 137654
First Posted: April 14, 2020    Key Record Dates
Last Update Posted: March 1, 2021
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases