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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 2
- 主要终点
- 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)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who present to the Emergency department and are categorized between 2-5 on the Canadian Triage & Acuity Scale (CTAS) scoring scale.
排除标准
- •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.
研究组 & 干预措施
Tyto Device
examination with Tyto device carried out by a nurse and sent online to the principle and co-investigators for remote analysis.
干预措施: Tyto Device (Device)
结局指标
主要结局
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)
时间窗: up to 6 hrs
during the visit to the emergency department.
次要结局
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(up to 6 hrs)
研究者
waisman yehezkel
Associate Professor, MD
Rabin Medical Center