Clinical trial NCT04570189: Evaluating Auscul-X, a Touch Free Digital Stethoscope
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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Lead sponsor: AusculSciences Canada Inc.
Sponsor class: INDUSTRY
Collaborators: name: Ottawa Heart Institute Research Corporation
First posted: 2020-09-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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

Eligibility 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

Primary outcomes:
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.
timeFrame: up to 1 Year
Secondary outcomes:
measure: 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.
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The University of Ottawa Heart Institute
state: Ontario
Study officials:
affiliation: Ottawa Heart Institue Research Foundation
name: Benjamin Chow, MD
role: PRINCIPAL_INVESTIGATOR
References: