Evaluating Auscul-X, a Touch Free Digital Stethoscope

Sponsor
AusculSciences Canada Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04570189
Collaborator
Ottawa Heart Institute Research Corporation (Other)
40
1
3
13.2

Study Details

Study Description

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)

Condition or Disease Intervention/Treatment Phase
  • Device: Auscul-X

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

Study Design

Study Type:
Observational
Anticipated Enrollment :
40 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
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)
Actual Study Start Date :
Oct 1, 2020
Anticipated Primary Completion Date :
Jan 1, 2021
Anticipated Study Completion Date :
Jan 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Phase I

Twenty subjects, 10 unventilated and 10 ventilated patients, will undergo clinical auscultation of the heart and lungs with the Auscul-X, a conventional stethoscope and an electronic stethoscope (Littmann 3200).

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

Phase II

Twenty subjects, 10 unventilated and 10 ventilated patients, will undergo clinical auscultation of the heart and lungs with an Auscul-X with wireless capability, a conventional stethoscope and an electronic stethoscope (Littmann 3200). Phase II shall begin upon appropriate Health Canada approvals for the Auscul-X with wireless capability.

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

Outcome Measures

Primary Outcome Measures

  1. 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 Year]

    To determine the feasibility of implementing Auscul-X in the critical/intensive care environment (ICCU and CSICU).

Secondary Outcome Measures

  1. 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 year]

    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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The University of Ottawa Heart Institute Ottawa Ontario Canada K1Y 4W7

Sponsors and Collaborators

  • AusculSciences Canada Inc.
  • Ottawa Heart Institute Research Corporation

Investigators

  • Principal Investigator: Benjamin Chow, MD, Ottawa Heart Institue Research Foundation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
AusculSciences Canada Inc.
ClinicalTrials.gov Identifier:
NCT04570189
Other Study ID Numbers:
  • Auscul-X
First Posted:
Sep 30, 2020
Last Update Posted:
Dec 14, 2020
Last Verified:
Dec 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 14, 2020