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NCT04570189 Clinical Trial

Evaluating Auscul-X, a Touch Free Digital Stethoscope

COVID-19 Clinical Trial

Official title:
Evaluating Auscul-X, a Touch Free Digital Stethoscope, for Physical Distancing to Protect Patients and Health Care Professionals From COVID-19 (The Auscul-X Study)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04570189
Other study ID # Auscul-X
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2020
Est. completion date January 2021

Study information
Verified date December 2020
Source AusculSciences Canada Inc.
Contact Melissa Spero, CRN, CCRP
Phone 613 763 0088
Email melissa@ausculsciences.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Auscul-X a touch free digital stethoscope will permit physical distancing of healthcare providers while maintaining the ability to auscultate patients from a safe distance (over 10 feet away)

Description:

The Auscul-X System (AusculSciences Canada, Inc.), is novel, professional grade, touch free, multichannel, touch-free electronic stethoscope with disposable elements designed to protect HCPs from exposure to infection diseases by allowing them to auscultate patients from a safe distance (10 feet away). The sensors can stay in place and enable providers to listen on-demand to a patient's heart and lungs over an extended period of time. This practice of distancing in the workplace is a key CDC and PHAC recommendation to protect the frontline HCP from exposure risk to the highly contagious COVID- 19 virus and other communicable diseases. The Auscul-X not only has the potential to better protect HCPs from infection, but also eliminates the potential transmission of pathogens through the use of conventional stethoscopes. In addition, the Auscul-X allows multiple HCPs to listen to the patient's heart and lung sounds simultaneously

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date January 2021
Est. primary completion date January 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - >/=18 years old - Admitted to ICCU and CSICU at UOHI Exclusion Criteria: - Age < 18 years old - Medically Unstable - Chest wall deformity or wounds in adhesive application areas - Unwillingness or inability to provide Informed Consent or to comply with protocol

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Auscul-X
The Auscul-X System (AusculSciences Canada, Inc.), is novel, professional grade, touch free, multichannel, touch-free electronic stethoscope with disposable elements designed to protect HCPs from exposure to infection diseases by allowing them to auscultate patients from a safe distance (10 feet away). The sensors can stay in place and enable providers to listen on-demand to a patient's heart and lungs over an extended period of time. This practice of distancing in the workplace is a key CDC and PHAC recommendation to protect the frontline HCP from exposure risk to the highly contagious COVID- 19 virus and other communicable diseases. The Auscul-X not only has the potential to better protect HCPs from infection, but also eliminates the potential transmission of pathogens through the use of conventional stethoscopes. In addition, the Auscul-X allows multiple HCPs to listen to the patient's heart and lung sounds simultaneously

Locations
Country Name City State
Canada The University of Ottawa Heart Institute Ottawa Ontario

Sponsors (2)
Lead Sponsor Collaborator
AusculSciences Canada Inc. Ottawa Heart Institute Research Corporation

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Feasibility and use of Auscul-X for listening to heart and lung sounds will be assessed by ICU clinicians to determine Auscul-X is at least equivalent to a digital stethoscope using a Likert scale for comparison. To determine the feasibility of implementing Auscul-X in the critical/intensive care environment (ICCU and CSICU). up to 1 Year
Secondary The measurement for acoustic quality in high risk settings determined as clarity and loudness by means of a Likert scale for comparison of Auscul-X and digital stethoscopes by clinicians. Determine if the quality of the real-time heart and lung sounds (Likert scale) for the Auscul-X will be similar to the conventional stethoscope and digital electronic stethoscope in the ICCU and CSICU (Appendix A).
Determine if the acoustic recordings taken as part of Phase II for the Auscul-X and conventional electronic stethoscope are similar (as evaluated by independent blinded cardiologists and respirologists using a Likert scale for acoustic and diagnostic quality (Appendix B)).
Determine if the acoustic recordings for the Auscul-X and conventional electronic stethoscope provide similar signal quality using objective acoustic metrics (e.g. signal to noise ratios, etc.) (Phase II only)		 up to 1 year
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