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:

  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.

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