Thoracic Injuries Clinical Trial
Official title:
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.
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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