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No diagnosis of visceral lesion was placed on 18 included patients. The study is thus stopped prematurely for ethical reasons.
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| Name | Class |
|---|---|
| France Telecom R&D | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robot-Based Tele-Echography (TER) | Experimental | ultrasound performed according to the method Tele-Echography |
|
| ultrasound method FAST | Active Comparator | ultrasound performed according to the method FAST (Focused Assessment Sonography for Trauma) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robot-Based Tele-Echography (TER) | Device | Robot-Based Tele-Echography, ultrasound performed by the radiologist |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Jacques Banihachemi, MD | Urgences Traumatologiques de l'hôpital SUD - Centre Hospitalier et Universitaire - Grenoble - B.P. 185 38042 GRENOBLE Cedex 09 - France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Grenoble | 38000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14663989 | Background | Vilchis A, Masuda K, Troccaz J, Cinquin P. Robot-based tele-echography: the TER system. Stud Health Technol Inform. 2003;95:212-7. |
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| ID | Term |
|---|---|
| D000007 | Abdominal Injuries |
| D013898 | Thoracic Injuries |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ultrasound method FAST | Device | FAST,ultrasound performed by the emergency doctor |
|