The Efficacy and Safety of Using the Novel Tyto Device

NCT ID: NCT02723890

Last Updated: 2018-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2018-04-30

Brief Summary

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

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)

Conditions

Pharyngitis; Respiratory Diseases; Cardiac Diseases; Ear Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Tyto Device

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

Group Type: EXPERIMENTAL

Tyto Device

Intervention Type: DEVICE

Interventions

Tyto Device

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rabin Medical Center

OTHER

Sponsor Role: lead

Responsible Party

waisman yehezkel

Associate Professor, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Petah Tikva, , Israel

Countries

Israel

Other Identifiers

RMC-15-0266

Identifier Type: -

Identifier Source: org_study_id