An observational study in COVID-19, sponsored by London Health Sciences Centre OR Lawson Research Institute of St. Joseph's. Terminated at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-01.
Sponsored by London Health Sciences Centre OR Lawson Research Institute of St. Joseph's · Observational
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 21 is below the median of 260 across 3,135 observational studies indexed under COVID-19.
Browse COVID-19 studies →London Health Sciences Centre OR Lawson Research Institute of St. Joseph's is the lead sponsor of 25 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients presenting to the emergency department with respiratory distress requiring non-invasive ventilation.
Exclusion Criteria:
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
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 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.
Patient will be put on BIPAP using the standard mask
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.
Time frame: Baseline to 24 hours
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 24 hours
Plan to share: Undecided
No publications or documents are linked to this record.
This study is terminated, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
London Health Sciences Centre OR Lawson Research Institute of St. Joseph's