COVID-19 and Lung Ultrasound Utility

The Utility of Self-administered Lung Ultrasound in Patients With COVID-19

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.

Study Overview

• Status: Completed
• Conditions: Covid19; Lung Infection
• Intervention / Treatment: Device: Butterfly iQ

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Markham, Ontario, Canada, L3P 7P3
      • Markham Stouffville Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: LUS ultrasound and standard of care; Subjects will perform a lung ultrasound in order to determine the ability of patients to take an ultrasound from their homes. The lung ultrasound will be coupled with telehealth clinical support to monitor the severity of COVID-19 patients and provide standard of care. All subjects will receive the lung ultrasound technology and daily calls for teleguidance through the ultrasound and standard of care to monitor symptoms.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
If patients can perform lung ultrasound.	Patients will perform a lung ultrasound with teleguidance from a medical professional. This will be taken daily and monitored by an expert clinician who can guide based on the remote live transmission and probe position.	This will take place over a 14 day period of time.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlate LUS radiographic findings with patient outcomes	The LUS radiographic findings will be assessed to determine a possible correlation between the radiographic findings and disease timeline, clinical symptoms, ER visits, and hospital admissions. The score from radiographic assessment will be compared to the course of a subject's illness.	These correlations will be assessed over a 14-day period of time while the patient is enrolled in the study.

Collaborators and Investigators

• Sponsor: Bridge to Health Medical and Dental USA
• Investigators: Principal Investigator: William Cherniak, MD, MPH, Bridge to Health Medical and Dental USA

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2020
• Primary Completion (Actual): June 9, 2021
• Study Completion (Actual): June 9, 2021

Study Registration Dates

• First Submitted: September 15, 2020
• First Submitted That Met QC Criteria: October 15, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): July 14, 2021
• Last Update Submitted That Met QC Criteria: July 12, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 0001 (Researcher)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Notes pertaining to performance characterization of the device, as well as imaging data for additional quantitative evaluation of the image quality will be collected. This date is recorded for future device development. No IPD will be made available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes