Clinical Validation of Tele-stethoscope System Digital Bluetooth Ehas-fundatel
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Intra-observer agreement for heart murmurs auscultation using the two methods (tele-stethoscope and conventional stethoscope)
研究概览
简要总结
Acute respiratory infections and other respiratory and cardiology diseases like COPD or heart failure are important causes of morbidity and mortality around the world. Telemedicine is defined as the delivery of health care and the sharing of medical knoledge over distances using telecommunication systems. Inexpensive techologies offer the possibility of a direct, real-time connection between the patient or the other end. These technologies help to the physicians to manage different symptoms and cardio-respiratory diseases. A real-time wireless tele-stethoscopy system was designed to allow a physician to receive real-time cardio-respiratory sounds from a remote auscultation, as well as video images showing where the technician is placing the stethoscope on the patient´s body. Actually, the lack of physicians in rural areas of developing countries makes difficult their correct diagnosis and treatment. Furthermore, in the majority of health systems, the patients are shared between primary care and medical specialty in hospitals. The tele-stethoscopy system through telemedicine could help to the physicians or health-care technicians in the majority of health systems and especially in rural areas of developing countries without physicians to manage the patients. For this reason, the goal of this project is the clinical validation of an open real-time tele-stethoscope systme (EHAS-Fundatel digital stethoscope) previously designed, with different specialist (pneumologists, cardiologists and internists.)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent sign.
- •Pacient admitted to hospital with any disease but no inestable disease.
排除标准
- •The lack of informed consent.
- •Inestable disease.
结局指标
主要结局
Intra-observer agreement for heart murmurs auscultation using the two methods (tele-stethoscope and conventional stethoscope)
时间窗: change from baseline auscultation to final auscultation (after 1 hour)
The investigators will randomize the first auscultation (baseline auscultation) into tele-stethoscope system or conventional stethoscope. After 1 hour, we will use the other auscultation method. The investigators will measure if there is a heart murmur or not and the intra-observer agreement by the kappa index in the heart murmurs auscultation.
Intra-observer agreement for vesicular murmur auscultation using the two methods (tele-stethoscope and conventional stethoscope)
时间窗: change from baseline auscultation to final auscultation (after 1 hour)
The investigators will measure if there is a normal vesicular murmur or not and the intra-observer agreement by the kappa index in the vesicular murmur auscultation.
Intra-observer agreement for heart rhythm auscultation using the two methods (tele-stethoscope and conventional stethoscope)
时间窗: change from baseline auscultation to final auscultation (after 1 hour)
The investigators will measure if there is a heart rhythm auscultation or not rhythm and the intra-observer agreement by the kappa index in the heart rhythm auscultation.
Intra-observer agreement for lung rales sounds using the two methods (tele-stethoscope and conventional stethoscope)
时间窗: change from baseline auscultation to final auscultation (after 1 hour)
The investigators will measure if there is a lung rale sound or not and the intra-observer agreement by the kappa index in the lung rale sound.
次要结局
- Inter-observer agreement for heart rhythm auscultation using the two methods (tele-stethoscope and conventional stethoscope)(change from baseline auscultation to final auscultation (after 1 hour))
- Inter-observer agreement for vesicular murmur auscultation using the two methods (tele-stethoscope and conventional stethoscope)(change from baseline auscultation to final auscultation (after 1 hour))
- Inter-observer agreement for for heart murmurs auscultation using the two methods (tele-stethoscope and conventional stethoscope)(change from baseline auscultation to final auscultation (after 1 hour))
- Inter-observer agreement for lung rales sounds using the two methods (tele-stethoscope and conventional stethoscope)(change from baseline auscultation to final auscultation (after 1 hour))
研究者
Jaime Corral Penafiel
medical doctor
Sociedad Española de Neumología y Cirugía Torácica