The Efficacy and Safety of Using the Novel Tyto Device

Study Overview
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Brief Summary
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To investigate the efficacy and safety of using the novel Tyto device for remote physical examination by co-investigators as compared to a standard medical physical examination by physicians.

Detailed Description
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A single center, prospective, qualitative study. Patients referred to the emergency department will be triaged according to The Canadian Triage & Acuity Scale (CTAS). Patients presenting with complaints suitable for examination with the Tyto device (ear/throat/respiratory/cardiac complaints) and meeting the inclusion criteria will be informed and asked for consent. Patients participating in the study will be referred to a room dedicated for the purpose. A minimum of a hundred volunteer patients will be selected and enrolled for a preliminary Pilot Study. Final study design and its extent will be determined accordingly. Physical examinations using the Tyto device will be performed by the co-investigators, and sent online to the principle investigator for remote analysis. The emergency department physician will examine the patient using conventional examination instruments (i.e. stethoscope, otoscope). The data collected will be recorded on predetermined case report form (CRF), timed, stored and analyzed by the principle and co-investigators. The findings of the co-investigators' examination will be compared to the conventional examination instruments used by the emergency department physician. Results will be checked and compared categorically (0-inconclusive; 1-normal; 2-pathological findings)

Official Title
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The Efficacy and Safety of Using the Novel Tyto Device for Remote Physical Examination by a Physician as Compared to a Standard Medical Physical Examination

Conditions
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Pharyngitis, Respiratory Diseases, Cardiac Diseases, Ear Infection

Intervention / Treatment
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* Device: Tyto Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who present to the Emergency department and are categorized between 2-5 on the Canadian Triage & Acuity Scale (CTAS) scoring scale. Exclusion Criteria: CTAS 1. Pregnant adolescent. Multi-drug resistant carriers. Intellectual disability disorders. Unsigned informed consent. Patients with CTAS score of 2-3, will be first addressed by a physician to ascertain their eligibility to be enrolled to the study.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tyto Device<br>examination with Tyto device carried out by a nurse and sent online to the principle and co-investigators for remote analysis. | Device: Tyto Device<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The concordance of diagnosis and physical findings using the Tyto device on the heart, lung ear and throat as compared to standard physical examination (normal heart and lung sounds, arrhythmia, crackles, normal appearance of ear and throat or otherwise) | during the visit to the emergency department. | up to 6 hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | during the visit to the emergency department. | up to 6 hrs |