Assessment of the echOpen Ultra-portable Ultrasound Device in Daily Use by Clinicians. Part I: Identification of Effusion and Detection of Basilic Vein
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 201
- 试验地点
- 8
- 主要终点
- Presence of Pleural effusion
研究概览
简要总结
In recent years, portable and ultra-portable ultrasound devices are increasingly used by the non radiologists, notably cardiologists or obstetrician gynecologist, at the patient's bedside to visualize and measure anatomical structures and fluid and provide the clinical examination with additional signs allowing quicker and more confident clinical decisions.
This innovative approach is slowed down by the accessibility of these miniaturized devices, the price of which remains high.
The echOpen device includes an ultra-portable ultrasound probe and a mobile application that allows the image to be displayed on a smartphone via a WIFI protocol.
The objective of the clinical investigation is to show that the echOpen device, using three frequencies 3.5 Mhz, 5.0 Mhz and 7.5 Mhz, allows identifying the semiological signs or anatomical structures of interest located at several depths of the body, with a performance similar to other devices routinely used in clinical departments.
详细描述
The echOpen device includes an ultrasound probe and a mobile application. The mechanical probe emits at three ultrasound frequencies, 3.5 Mhz, 5.0 Mhz and 7.5 Mhz, which allows the exploration of the interior of the body at different depths in a non-invasive and non-irradiating manner.
Thus, the purpose of the echOpen device is, on one hand, to guide the diagnosis during the clinical examination and, on the other hand, to identify anatomical structures in order to assist in management.
The objective of the clinical investigation is to demonstrate that the echOpen device is able to identify semiological signs and localize anatomical structures at different depths of the body, with a performance not inferior to that of other ultrasound devices, routinely employed in hospital clinical departments.
The signs of interest (i.e. search for an intra-abdominal (3.5 Mhz) and pleural (5.0 Mhz) effusion) were chosen for their clinical usefulness (their presence during the clinical examination constitutes an argument for orientation and/or severity) and for their prevalence in the study population.
The identification of anatomical structure of interest (i.e. detection of basilic vein (7.5Mhz)) was chosen because it is a gesture frequently used when taking in charge of a patient hospitalized in the selected departments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
盲法说明
Open Label
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient (age ≥ 18 years old)
- •Patient having signed the informed consent to participate in this clinical investigation
- •Patient affiliated to the social security scheme
- •Patient arriving in the hospital clinical ward (own initiative or by emergency services) whose clinical symptomatology (e.g. dyspnea, thoracic pain, etc.) suggests the presence of pathological elements (effusion) which would be visible using an ultrasound probe
- •Patient consulting in the hospital clinical ward who could potentially benefit from a basilic vein line placement using an ultrasound device
排除标准
- •Minor patient (age < 18 years)
- •Patients under the "State medical assistance"
- •Obese patient (body mass index > 29.9)
- •Patient in too serious condition for the clinical examination to be done fully and/or with additional exploratory time
- •Unstable patient: need for immediate care, impossibility to carry out a thorough clinical examination including interview, palpation, auscultation, percussion
- •Known allergy to ultrasound gel
结局指标
主要结局
Presence of Pleural effusion
时间窗: Day 0
Presence or absence of pleural effusion as assessed by the echOpen device or by a portable ultrasound routinely used in the department
Presence of Intra-abdominal effusion
时间窗: Day 0
Presence or absence of intra-abdominal effusion as assessed by the echOpen device or by a portable ultrasound routinely used in the department
Basilic vein identification
时间窗: Day 0
Successful identification of the basilic vein using the echOpen device or a portable ultrasound routinely used in the department
次要结局
- Plural effusion detected using a gold standard procedure(Day 0)
- Basilic vein identification using a gold standard procedure(Day 0)
- Intra-abdominal effusion detected using a gold standard procedure(Day 0)