Ultrasounds are usually done by a specially trained health professional in the hospital or emergency department (ED) setting. Using a novel single-probe device, the ultrasound can be plugged into an iOS / Android device. The purpose of this research is to assess the usefulness of lung ultrasound imaging, performed by the patient in the home setting for the management of the COVID-19 disease using this novel highly-portable ultrasound.
This will be a prospective self-controlled design. The study subjects will receive a
telehealth visit from a healthcare provider (HCP) to assess for any change in their COVID-19
symptoms. The HCP will recommend the patient remain at home, or to go to an emergency
department based on standard of care and clinical decision making. Subsequently, the study
subjects will receive a teleguidance session with a Radiologist who is trained in lung
ultrasound (LUS) in order to obtain images of their chest. The physician performing LUS
remotely will report LUS findings in a standard quality assurance (QA) document, including
image quality, interpretation, and recommendations. This QA report will be study data and not
shared with the patient. The two providers will be blinded, except when there is a
disagreement between the Telemed LUS and clinical interview.
The study staff will determine when this disagreement occurs. They will notify the study
investigators and radiologist, who will then discuss and come to an agreement within 24
hours. If deemed concerning, they will then contact the HCP and unblind them as to the
radiographic findings. There will be no delay in medical care advised by the subject's HCP.
Specifically, the nurse will inform the HCP by a phone call that the physician performing LUS
remotely found a significant change in LUS findings. The HCP will then be given access to the
LUS report (as well as images if desired), and will review the decision to seek medical care
with the telemed doctor.
Device: Butterfly iQ
The Butterfly iQ is an ultrasound system that enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric patients. It is a non-invasive device and does not impose any health hazards.
Inclusion Criteria:
- Must be 18 years or older and able to provide a valid informed consent.
- Must have a nasal swab positive RT-PCR for COVID-19
- Must have access to Wi-Fi at home
Exclusion Criteria:
- Subjects unwilling or unable to directly provide consent.
- The following vulnerable study subject populations will not be eligible: prisoners,
mentally impaired, or disadvantaged groups.
- Any condition deemed by the principal investigator, in his or her judgment, that may
impact the subject's ability to meet the requirements necessary to collect the exam
data required.
Markham Stouffville Hospital
Markham, Ontario, Canada
William Cherniak, MD, MPH, Principal Investigator
Bridge to Health Medical and Dental USA