The Efficacy and Safety of Using the Novel Tyto Device

Not Applicable

Completed

• Conditions: Cardiac Diseases; Pharyngitis; Respiratory Diseases; Ear Infection
• Interventions: Device: Tyto Device

• Registration Number: NCT02723890
• Lead Sponsor: Rabin Medical Center

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)

Study Timeline

• Study First Submitted: 2016-03-01
• Study First Submitted QC: 2016-03-24
• Study First Posted: 2016-03-31
• Study Start: 2016-07
• Primary Completion: 2017-01
• Status Verified: 2018-04
• Study Completion: 2018-04
• Last Update Submitted: 2018-04-22
• Last Update Posted: 2018-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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)	up to 6 hrs	during the visit to the emergency department.

Secondary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	up to 6 hrs	during the visit to the emergency department.

Trial Locations

Locations (1)

Dept. of Emergency Medicine, Schneider Children's Medical Center of Israel; 🇮🇱 Petach Tikva, Israel