Clinical Trial: Robot-based Tele-echography II - A Comparative Study
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
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.
Brief Summary: 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 Summary:
- 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.
Sponsor: University Hospital, Grenoble
Current Primary Outcome: 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. [ Time Frame: 6 month ]
Original Primary Outcome: - 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.
Current Secondary Outcome:
- sensitivity, specificity, PPV, NPV are estimated with a 95% confidence interval [ Time Frame: 6 month ]
- qualitative scores (including comfort and experience of the patient, quality of the echographic method evaluated by the physicians). [ Time Frame: 6 month ]
Original Secondary Outcome:
- - Outcome 2: sensitivity, specificity, PPV, NPV are estimated with a 95% confidence interval
- - Outcome 3: qualitative scores (including comfort and experience of the patient, quality of the echographic method evaluated by the physicians).
Information By: University Hospital, Grenoble
Dates:
Date Received: February 21, 2006
Date Started: February 2006
Date Completion:
Last Updated: September 14, 2016
Last Verified: September 2016