NCT04967729

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable covid19

Timeline
Completed

Started Jun 2021

Typical duration for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 10, 2021

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

July 7, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 20, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2022

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

9 months

First QC Date

July 7, 2021

Last Update Submit

April 13, 2023

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

  • The efficacy of image-acquisition for patient-performed lung ultrasound as assessed by a standard Quality Assurance, including image quality, interpretation, and recommendations.

    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. The efficacy of the images obtained will be assessed using a standard Quality Assurance report using Soldati scoring which will be completed and synthesized following each appointment during the fourteen day period.

    14 days

Secondary Outcomes (1)

  • Correlate LUS radiographic findings with patient outcomes.

    14 days

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: Device: Butterfly iQ

Interventions

Device: Butterfly iQDEVICE

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

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rocket Doctor Inc.

Toronto, Ontario, M5T1X5, Canada

Location

Related Publications (1)

  • Elmi N, Sadri Y, Myslik F, Chenkin J, Cherniak W. Self-administered at-home lung ultrasound with remote guidance in patients without clinical training. Respir Res. 2024 Mar 5;25(1):111. doi: 10.1186/s12931-024-02744-y.

    PMID: 38443957DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 7, 2021

First Posted

July 20, 2021

Study Start

June 10, 2021

Primary Completion

March 7, 2022

Study Completion

June 6, 2022

Last Updated

April 18, 2023

Record last verified: 2023-04

Locations

CA(1)