Efficacy of the echOpen Device to Identify Effusion and to Detect Basilic Vein (CLIN-ECHO-I)

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

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.

Study Overview

• Status: Completed
• Conditions: Pleural Effusion; Abdominal Effusion; Procedural Guidance
• Intervention / Treatment: Device: EchOpen ultra-portable ultrasound device; Device: Ultrasound device routinely used in the department.; Procedure: Standard ultrasound examination by an independent referent radiologist

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.

• Study Type: Interventional
• Enrollment (Actual): 201
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bobigny, France, 93140
    • Avicenne Hospital - APHP - Hepatology Department
  • Paris, France, 75014
    • Cochin Hospital - APHP - Emergency Department
  • Paris, France, 75014
    • Cochin Hospital - APHP - Pneumology department
  • Villejuif, France, 94800
    • Paul Brousse Hospital - APHP - Hepatobiliary Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients benefitting ultrasound examination; This is the only arm of the study. Patients with an indicative clinical picture that leads the clinician to resort to the use of an ultrasound to potentially support the diagnosis will be examined to verify the presence of pleural effusion or intra-abdominal effusion, or to identify basilic vein. The patients will be assessed first with the echOpen device and second witn an ultrasound routinely used in the department. 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

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; Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: EIT Health; ECHOPEN
• Investigators: Principal Investigator: Jérôme BOKOBZA, MD, AP-HP, Cochin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2022
• Primary Completion (Actual): August 19, 2022
• Study Completion (Actual): August 19, 2022

Study Registration Dates

• First Submitted: March 4, 2022
• First Submitted That Met QC Criteria: March 4, 2022
• First Posted (Actual): March 15, 2022

Study Record Updates

• Last Update Posted (Estimate): December 8, 2022
• Last Update Submitted That Met QC Criteria: December 7, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Ultrasound; Ultrasonography; Point-of-care-ultrasound; Pleural Effusion; Abdominal Effusion; Basilic vein
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pleural Effusion
• Other Study ID Numbers: APHP210065; 2021-A00341-40 (Other Identifier: IDRCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No