The Efficacy and Safety of Using the Novel Tyto Device

Clalit Health Services

Status: Completed

Conditions: Ear Infection; Cardiac Diseases; Pharyngitis; Respiratory Diseases

Treatments: Device: Tyto Device

Study type: Interventional

Funder types: Other

Identifiers

NCT02723890

RMC-15-0266

Details and patient eligibility

About

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.

Full description

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)

Enrollment: 136 patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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136 participants in 1 patient group

Tyto Device

Experimental group

Description:

examination with Tyto device carried out by a nurse and sent online to the principle and co-investigators for remote analysis.

Treatment:

Device: Tyto Device