Efficacy of the echOpen Device to Identify Effusion and to Detect Basilic Vein

Pleural Effusion Clinical Trial

— CLIN-ECHO-I  

Official title:

Assessment of the echOpen Ultra-portable Ultrasound Device in Daily Use by Clinicians. Part I: Identification of Effusion and Detection of Basilic Vein

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05280119
• Other study ID #: APHP210065
• Secondary ID: 2021-A00341-40
• Status: Completed
• Phase: N/A
• Start date: April 4, 2022
• Est. completion date: August 19, 2022

Study information

• Verified date: December 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: August 19, 2022
• Est. primary completion date: August 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pleural Effusion

Intervention

Device:
• EchOpen ultra-portable ultrasound device
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
• Ultrasound 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.

Procedure:
• Standard 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

Locations

Country	Name	City	State
France	Avicenne Hospital - APHP - Hepatology Department	Bobigny
France	Cochin Hospital - APHP - Emergency Department	Paris
France	Cochin Hospital - APHP - Pneumology department	Paris
France	Paul Brousse Hospital - APHP - Hepatobiliary Center	Villejuif

Sponsors (3)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	ECHOPEN, EIT Health

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of Pleural effusion	Presence or absence of pleural effusion as assessed by the echOpen device or by a portable ultrasound routinely used in the department	Day 0
Primary	Presence of Intra-abdominal effusion	Presence or absence of intra-abdominal effusion as assessed by the echOpen device or by a portable ultrasound routinely used in the department	Day 0
Primary	Basilic vein identification	Successful identification of the basilic vein using the echOpen device or a portable ultrasound routinely used in the department	Day 0
Secondary	Plural effusion detected using a gold standard procedure	Presence of pleural effusion determined by an independent referent radiologist using a standard ultrasound machine	Day 0
Secondary	Intra-abdominal effusion detected using a gold standard procedure	Presence or absence of intra-abdominal effusion determined by an independent referent radiologist using a standard ultrasound machine	Day 0
Secondary	Basilic vein identification using a gold standard procedure	Identification of the basilic vein by an independent referent radiologist using a standard ultrasound machine	Day 0