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The Efficacy and Safety of Using the Novel Tyto Device

Primary Purpose

Pharyngitis, Respiratory Diseases, Cardiac Diseases

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Tyto Device
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pharyngitis

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tyto Device

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
during the visit to the emergency department.

Full Information

First Posted
March 1, 2016
Last Updated
April 22, 2018
Sponsor
Rabin Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02723890
Brief Title
The Efficacy and Safety of Using the Novel Tyto Device
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
April 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rabin Medical Center

4. Oversight

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pharyngitis, Respiratory Diseases, Cardiac Diseases, Ear Infection

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tyto Device
Arm Type
Experimental
Arm Description
examination with Tyto device carried out by a nurse and sent online to the principle and co-investigators for remote analysis.
Intervention Type
Device
Intervention Name(s)
Tyto Device
Primary Outcome Measure Information:
Title
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)
Description
during the visit to the emergency department.
Time Frame
up to 6 hrs
Secondary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Description
during the visit to the emergency department.
Time Frame
up to 6 hrs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Dept. of Emergency Medicine, Schneider Children's Medical Center of Israel
City
Petach Tikva
ZIP/Postal Code
4920235
Country
Israel

12. IPD Sharing Statement

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The Efficacy and Safety of Using the Novel Tyto Device

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