Clinical trial NCT04591158: COVID-19 and Lung Ultrasound Utility
Official title: The Utility of Self-administered Lung Ultrasound in Patients With COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Lung Infection
Lead sponsor: Bridge to Health Medical and Dental USA
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: If patients can perform lung ultrasound.
timeFrame: This will take place over a 14 day period of time.
Secondary outcomes:
measure: Correlate LUS radiographic findings with patient outcomes
timeFrame: These correlations will be assessed over a 14-day period of time while the patient is enrolled in the study.
Other outcomes:
Locations:
city: Markham
country: Canada
facility: Markham Stouffville Hospital
state: Ontario
Study officials:
affiliation: Bridge to Health Medical and Dental USA
name: William Cherniak, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: