The Efficacy and Safety of Using the Novel Tyto Device

Rabin Medical Center136 enrolled

Overview

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.

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)

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

136

Conditions

Pharyngitis Respiratory Diseases Cardiac Diseases Ear Infection

Interventions

Tyto DeviceDEVICE

Eligibility

Sex: ALLMin age: 2 YearsMax age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Dept. of Emergency Medicine, Schneider Children's Medical Center of Israel

Petah Tikva, Israel

Outcomes

Primary Outcomes

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.

Time frame: up to 6 hrs

Secondary Outcomes

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

during the visit to the emergency department.

Time frame: up to 6 hrs

Data from ClinicalTrials.gov

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