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Evaluating Auscul-X, a Touch Free Digital Stethoscope

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ClinicalTrials.gov Identifier: NCT04570189
Recruitment Status : Recruiting
First Posted : September 30, 2020
Last Update Posted : December 14, 2020
Sponsor:
Collaborator:
Ottawa Heart Institute Research Corporation
Information provided by (Responsible Party):
AusculSciences Canada Inc.

Study Description
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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
COVID-19 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
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Study Type : Observational
Estimated 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 : October 1, 2020
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021
Groups and Cohorts
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Group/Cohort 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
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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. [ Time Frame: 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. [ Time Frame: up to 1 year ]
    1. 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study will recruit 40 (Phase 1 = 20 patients, Phase 2 = 20 patients) adult participants age 18 years old, who are under care in the Intensive Cardiac Care Unit (ICCU) or Cardiac Surgical Intensive Care Unit (CSICU) at the University of Ottawa Heart Institute.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04570189


Contacts
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Contact: Melissa Spero, CRN, CCRP 613 763 0088 ext 107 melissa@ausculsciences.com
Contact: John Phillips, BSc. 613-763-0088 john@ausculsciences.com

Locations
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Canada, Ontario
The University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y 4W7
Contact: Farrah Ahmed, BSc.    613 696 7000 ext 12697    fahmed@ottawaheart.ca   
Principal Investigator: Benjamin Chow, MD,FRCPC         
Sub-Investigator: Aun Yeong Chong, BSc(Med),MD         
Sponsors and Collaborators
AusculSciences Canada Inc.
Ottawa Heart Institute Research Corporation
Investigators
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Principal Investigator: Benjamin Chow, MD Ottawa Heart Institue Research Foundation
More Information
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Responsible Party: AusculSciences Canada Inc.
ClinicalTrials.gov Identifier: NCT04570189    
Other Study ID Numbers: Auscul-X
First Posted: September 30, 2020    Key Record Dates
Last Update Posted: December 14, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No