Evaluating Auscul-X, a Touch Free Digital Stethoscope

NCT ID: NCT04570189

Last Updated: 2020-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-01

Study Completion Date

2021-01-31

Brief Summary

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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

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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

Conditions

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COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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).

Auscul-X

Intervention Type DEVICE

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.

Auscul-X

Intervention Type DEVICE

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

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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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ottawa Heart Institute Research Corporation

OTHER

Sponsor Role collaborator

AusculSciences Canada Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Benjamin Chow, MD

Role: PRINCIPAL_INVESTIGATOR

Ottawa Heart Institue Research Foundation

Locations

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The University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Melissa Spero, CRN, CCRP

Role: CONTACT

Phone: 613 763 0088

Email: [email protected]

John Phillips, BSc.

Role: CONTACT

Phone: 613-763-0088

Email: [email protected]

Facility Contacts

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Farrah Ahmed, BSc.

Role: primary

Other Identifiers

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Auscul-X

Identifier Type: -

Identifier Source: org_study_id