The Efficacy and Safety of Using the Novel Tyto Device

Pharyngitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02723890
• Other study ID #: RMC-15-0266
• Status: Completed
• Phase: N/A
• First received: March 1, 2016
• Last updated: April 22, 2018
• Start date: July 2016
• Est. completion date: April 2018

Study information

• Verified date: April 2018
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: April 2018
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Diseases
• Ear Infection
• Heart Diseases
• Otitis
• Pharyngitis
• Respiration Disorders
• Respiratory Diseases
• Respiratory Tract Diseases

Intervention

Device:
• Tyto Device

Locations

Country	Name	City	State
Israel	Dept. of Emergency Medicine, Schneider Children's Medical Center of Israel	Petach Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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