Trials / Terminated
TerminatedNCT00295438
Robot-based Tele-echography II - A Comparative Study
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.
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- University Hospital, Grenoble · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Robot-Based Tele-Echography (TER) | Robot-Based Tele-Echography, ultrasound performed by the radiologist |
| DEVICE | ultrasound method FAST | FAST,ultrasound performed by the emergency doctor |
Timeline
- Start date
- 2006-02-01
- Primary completion
- 2009-01-01
- Completion
- 2009-03-01
- First posted
- 2006-02-23
- Last updated
- 2016-09-15
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT00295438. Inclusion in this directory is not an endorsement.