Clinical Trials Directory

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

TypeNameDescription
DEVICERobot-Based Tele-Echography (TER)Robot-Based Tele-Echography, ultrasound performed by the radiologist
DEVICEultrasound method FASTFAST,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.