Robot-based Tele-echography II - A Comparative Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2009-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of this clinical trial is to evaluate the concordance of diagnosis of injuries in thoracoabdominal trauma using two different echographic methods. The first method is a robot-based tele-echography performed by radiologists in a remote location. The second is bedside echography performed by emergency physicians according to the FAST (Focussed Assessment by Sonography of Trauma) examination.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Phased-Array Versus Curvilinear Probe for FAST Ultrasonography

NCT07037797

Chest Trauma Abdominal Trauma

NOT_YET_RECRUITING NA

The Second Try During Landmark Approach of the Internal Jugular Vein: an Ultrasonographic Prelocation Study

NCT02492932

Jugular Veins

NOT_YET_RECRUITING NA

Utility of Point-of-care Device for Rapid Determination of Cogulopathy in Trauma Patients

NCT02869737

Severe Trauma

COMPLETED

Interest of Ultrasound Coupled to a Guidance System (GPS) for Central Venous Catheters (CVC) Insertion.

NCT02231528

Surgery

COMPLETED PHASE3

Incidence and Risk Factors of Central Line Catheter Related Thrombosis

NCT03450785

Central Line Complication

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

1. Principal objective: to evaluate the concordance of diagnosis of injuries in thoracoabdominal trauma using two different echographic methods (robot-based tele-echography performed by radiologists in a remote location vs bedside echography performed by emergency physicians according to the FAST examination).
2. Objective 2: after the realization of a gold standard method, if there is a concordance between the two different echographic methods, sensitivity and specificity are estimated. If not, the evaluation of sensitivity and specificity of each method with analysis of their discordance is performed.
3. Objective 3: qualitative evaluation of each echographic method by the patient and the physicians.
4. Material and methods: This therapeutic, mono-centre, prospective, randomized, cross-over, open, controlled trial is being conducted in 70 patients. All the patients will have the two different echographic methods in a sequential but randomized way. The robot-based tele-echography is performed by a radiologist in the North University Hospital of Grenoble. The bedside echography is performed by the emergency physicians in the trauma center in the South University Hospital of Grenoble.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Abdominal Injuries Thoracic Injuries High Energy Trauma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Robot-Based Tele-Echography (TER)

ultrasound performed according to the method Tele-Echography

Group Type EXPERIMENTAL

Robot-Based Tele-Echography (TER)

Intervention Type DEVICE

Robot-Based Tele-Echography, ultrasound performed by the radiologist

ultrasound method FAST

Intervention Type DEVICE

FAST,ultrasound performed by the emergency doctor

ultrasound method FAST

ultrasound performed according to the method FAST (Focused Assessment Sonography for Trauma)

Group Type ACTIVE_COMPARATOR

Robot-Based Tele-Echography (TER)

Intervention Type DEVICE

Robot-Based Tele-Echography, ultrasound performed by the radiologist

ultrasound method FAST

Intervention Type DEVICE

FAST,ultrasound performed by the emergency doctor

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Robot-Based Tele-Echography (TER)

Robot-Based Tele-Echography, ultrasound performed by the radiologist

Intervention Type DEVICE

ultrasound method FAST

FAST,ultrasound performed by the emergency doctor

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Person registered with the French Social Security or benefiting from an equivalent health insurance system
* Person sent to hospital for thoracoabdominal high energy trauma

Exclusion Criteria

* Ward of court or under guardianship
* Adult unable to express their consent
* Person deprived of freedom by judicial or administrative decision
* Person hospitalized without their consent
* Person under legal protection
* Person participating in another clinical study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No