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

NCT05280119 | Completed

• 2 other identifiers: APHP2100652021-A00341-40
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 4

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.

Conditions

Pleural Effusion; Abdominal Effusion; Procedural Guidance

Keywords

Ultrasound; Ultrasonography; Point-of-care-ultrasound; Pleural Effusion; Abdominal Effusion; Basilic vein

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Plural effusion detected using a gold standard procedure

  Day 0

• Intra-abdominal effusion detected using a gold standard procedure

  Day 0

• Basilic vein identification using a gold standard procedure

  Day 0

Study Arms (1)

Patients benefitting ultrasound examination

EXPERIMENTAL

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; Device: Ultrasound device routinely used in the department.; Procedure: Standard ultrasound examination by an independent referent radiologist

Interventions

EchOpen ultra-portable ultrasound device 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

Patients benefitting ultrasound examination

Ultrasound device routinely used in the department. DEVICE

Patients who were first examined with the EchOpen ultra-portable ultrasound device, are secondarily examined with an ultrasound probe used routinely in the department.

Patients benefitting ultrasound examination

Standard ultrasound examination by an independent referent radiologist PROCEDURE

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

Patients benefitting ultrasound examination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• ECHOPEN: collaborator
• EIT Health: collaborator

Study Sites (4)

Avicenne Hospital - APHP - Hepatology Department

Bobigny, 93140, France

Location

Cochin Hospital - APHP - Emergency Department

Paris, 75014, France

Location

Cochin Hospital - APHP - Pneumology department

Paris, 75014, France

Location

Paul Brousse Hospital - APHP - Hepatobiliary Center

Villejuif, 94800, France

Location

MeSH Terms

Conditions

Pleural Effusion

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Study Officials

• Jérôme BOKOBZA, MD

  AP-HP, Cochin Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Open Label
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: March 4, 2022
• First Posted: March 15, 2022
• Study Start: April 4, 2022
• Primary Completion: August 19, 2022
• Study Completion: August 19, 2022
• Last Updated: December 8, 2022

Record last verified: 2022-12

Locations

FR (4)