COVID-19 and Lung Ultrasound Utility

NCT04591158 | Completed FDA Device

• 1 other identifier: 0001
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Lung Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Correlate LUS radiographic findings with patient outcomes

  These correlations will be assessed over a 14-day period of time while the patient is enrolled in the study.

Study Arms (1)

LUS ultrasound and standard of care

OTHER

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

Interventions

Butterfly iQ 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.

LUS ultrasound and standard of care

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bridge to Health Medical and Dental USA: lead

Study Sites (1)

Markham Stouffville Hospital

Markham, Ontario, L3P 7P3, Canada

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• William Cherniak, MD, MPH

  Bridge to Health Medical and Dental USA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Providers are blinded from the subject's information from the clinical interviews when assessing LUS ultrasound findings, but will be unblinded when there is a disagreement between clinical and LUS findings. This allows information about the course of a subject's illness to not affect the LUS ultrasound findings.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: October 19, 2020
• Study Start: September 15, 2020
• Primary Completion: June 9, 2021
• Study Completion: June 9, 2021
• Last Updated: July 14, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)