COVID-19 and Lung Ultrasound Utility

NCT ID: NCT04591158

Last Updated: 2021-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-15
• Study Completion Date: 2021-06-09

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.

Conditions

Covid19; Lung Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Butterfly iQ

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bridge to Health Medical and Dental USA

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William Cherniak, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Bridge to Health Medical and Dental USA

Locations

Markham Stouffville Hospital

Markham, Ontario, Canada

Countries

Canada

Other Identifiers

0001

Identifier Type: -

Identifier Source: org_study_id