COVID-19NCT04344925
Non Invasive Positive Pressure Ventilation to Minimize Aerosolization for COVID 19
An observational study of COVID-19, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Aerosol-reducing Mask and Standard Mask
- Type of treatment
- Medical device
- How many people
- 21 participants
- Where
- 1 siteCanada
- Study dates
- 18 Apr 2020to 27 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients presenting to the emergency department with respiratory distress requiring non-invasive ventilation.
Who may be able to join
- Patient with respiratory failure due to primary pulmonary pathology.
- Patient who is selected for BiPAP or CPAP by the health care provider
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Aerosol-reducing Mask, Standard Mask
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerosol-reducing MaskDevice
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 MaskDevice
Patient will be put on BIPAP using the standard mask
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Standard Mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 24 hours
Secondary outcomes (7)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start18 Apr 2020
- Primary completion27 Nov 2020
- Study completion27 Nov 2020
Why it stopped: Device demonstrated to be less effective than the control mask in reducing leak
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04344925
- Sponsor's protocol ID
- 137654
- Status last verified
- Jun 2020
- First submitted
- 3 Apr 2020
- Last updated
- 1 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04344925
- Acronym / sponsor ID
- 137654
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Device demonstrated to be less effective than the control mask in reducing leak
- Enrolment
- 21 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 18 Apr 2020 (actual)
- Primary completion
- 27 Nov 2020 (actual)
- Study completion
- 27 Nov 2020 (actual)
- First posted
- 14 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerosol-reducing Mask | – | Device: Aerosol-reducing MaskThe 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. |
| Standard Mask | – | Device: Standard MaskThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients presenting to the emergency department with respiratory distress requiring non-invasive ventilation.
Key inclusion criteria (2 listed)
- Patient with respiratory failure due to primary pulmonary pathology.
- Patient who is selected for BiPAP or CPAP by the health care provider
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerosol-reducing MaskPatient 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. | Device | Aerosol-reducing Mask |
| Standard MaskPatient will be put on BIPAP using the standard mask | Device | Standard Mask |
Primary outcome
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.
7 secondary outcomes
Glasgow Coma Scale(GCS)
Time frame: Baseline to 24 hours
Respiratory Rate
Time frame: Baseline to 24 hours
Heart Rate
Time frame: Baseline to 24 hours
Metabolic Data: Blood Gas Measurements
Time frame: Baseline to 24 hours
Metabolic Data: Bicarbonate (HC03)
Time frame: Baseline to 24 hours
Metabolic Data: Partial Pressure of Carbon Dioxide (PaC02)
Time frame: Baseline to 24 hours
Metabolic Data: Partial Pressure of Oxygen (Pa02)
Time frame: Baseline to 24 hours
Results and safety
The study was stopped early (reason given: Device demonstrated to be less effective than the control mask in reducing leak). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Device demonstrated to be less effective than the control mask in reducing leak). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Leak Volume of Non Invasive Ventilation Mask (time frame: Baseline to 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2021.