Abdominal Effusion, Pleural Effusion, Procedural Guidance
Conditions
Keywords
Ultrasound, Ultrasonography, Point-of-care-ultrasound, Pleural Effusion, Abdominal Effusion, Basilic vein
Brief summary
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.
Detailed description
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. An ultrasound probe in use in the hospital clinical departments where the investigation takes place will be employed as a comparator to judge the performance of the echOpen device. This clinical investigation is part of a CE marking procedure.
Interventions
Depending on the clinical picture, patients are examined to detect the presence or absence of pleural effusion, or intra-abdominal effusion, or to localize the basilic vein
DEVICEUltrasound device routinely used in the department.
Patients who were first examined with the EchOpen ultra-portable ultrasound device, are secondarily examined with an ultrasound probe used routinely in the department.
PROCEDUREStandard ultrasound examination by an independent referent radiologist
In a case of discordance between the assessments made with echOpen and the usual ultrasound device, an independent referent radiologist will use a standard ultrasound machine to constitute the gold standard (GS) rating
Sponsors
ECHOPEN
EIT Health
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Masking description
Open Label
Intervention model description
A single group, comparative, non-randomized, controlled study. Each patient represents her/his own control: the patient is examined consecutively with the echOpen probe, then with the probe used in the department
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of Pleural effusion | 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 | 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 | Day 0 | Successful identification of the basilic vein using the echOpen device or a portable ultrasound routinely used in the department |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plural effusion detected using a gold standard procedure | Day 0 | Presence of pleural effusion determined by an independent referent radiologist using a standard ultrasound machine |
| Intra-abdominal effusion detected using a gold standard procedure | Day 0 | Presence or absence of intra-abdominal effusion determined by an independent referent radiologist using a standard ultrasound machine |
| Basilic vein identification using a gold standard procedure | Day 0 | Identification of the basilic vein by an independent referent radiologist using a standard ultrasound machine |
Countries
France
Outcome results
None listed