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Evaluating Auscul-X, a Touch Free Digital Stethoscope

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)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04570189
Enrollment
40
Registered
2020-09-30
Start date
2020-10-01
Completion date
2021-01-31
Last updated
2020-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Brief 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)

Detailed 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

Interventions

DEVICEAuscul-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

Sponsors

Ottawa Heart Institute Research Corporation
CollaboratorOTHER
AusculSciences Canada Inc.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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.up to 1 YearTo determine the feasibility of implementing Auscul-X in the critical/intensive care environment (ICCU and CSICU).

Secondary

MeasureTime frameDescription
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.up to 1 year1. 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). 2. 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)). 3. 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)

Countries

Canada

Contacts

Primary ContactMelissa Spero, CRN, CCRP
melissa@ausculsciences.com613 763 0088
Backup ContactJohn Phillips, BSc.
john@ausculsciences.com613-763-0088

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026