Recruiting

Auscultation Device

Sponsor:

AusculSciences Canada Inc.

Code:

NCT04570189

Conditions

COVID-19

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Auscul-X

Study Details

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)

Conditions

COVID-19

Study ID

NCT04570189

Start date

Oct 1, 2020

Status verified date

Dec, 2020

Completion date

Jan, 2021

Anticipated

Primary completion date

Jan, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

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).

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.

Interventions

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Melissa Spero, CRN, CCRP

613 763 0088melissa@ausculsciences.com

John Phillips, BSc.

613-763-0088john@ausculsciences.com

Locations

The University of Ottawa Heart Institute

Recruiting

Ottawa, Ontario, Canada, K1Y 4W7

Contacts

Farrah Ahmed, BSc.

613 696 7000fahmed@ottawaheart.ca

Principal Investigator:

Benjamin Chow, MD,FRCPC

More Information

Sponsor

AusculSciences Canada Inc.

Last update posted

Dec 14, 2020

Last verified

Dec, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by AusculSciences Canada Inc. on 2020-12-14.