Robot-based Tele-echography II - A Comparative Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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). 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. Objective 3: qualitative evaluation of each echographic method by the patient and the physicians. 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.

Official Title
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Robot-based Tele-echography II - A Comparative Study Using Two Echographic Modalities for Diagnosis of Thoracoabdominal Injuries at the Trauma Center of the Grenoble University Hospital.

Conditions
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Abdominal Injuries, Thoracic Injuries, High Energy Trauma

Intervention / Treatment
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* Device: Robot-Based Tele-Echography (TER)
* Device: ultrasound method FAST


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robot-Based Tele-Echography (TER)<br>ultrasound performed according to the method Tele-Echography | Device: Robot-Based Tele-Echography (TER)<br>* Robot-Based Tele-Echography, ultrasound performed by the radiologist<br>Device: ultrasound method FAST<br>* FAST,ultrasound performed by the emergency doctor<br>|
| Active Comparator: ultrasound method FAST<br>ultrasound performed according to the method FAST (Focused Assessment Sonography for Trauma) | Device: Robot-Based Tele-Echography (TER)<br>* Robot-Based Tele-Echography, ultrasound performed by the radiologist<br>Device: ultrasound method FAST<br>* FAST,ultrasound performed by the emergency doctor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The diagnosis concordance between the radiologists using the robot-based tele-echography and the emergency physicians (FAST bedside examination) is evaluated thanks to the Cohen kappa interrater agreement coefficient. |  | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensitivity, specificity, PPV, NPV are estimated with a 95% confidence interval |  | 6 month | 
| qualitative scores (including comfort and experience of the patient, quality of the echographic method evaluated by the physicians). |  | 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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robot-based tele-echography, tele-medicine