Clinical trial NCT00295438: Robot-based Tele-echography II - A Comparative Study
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Abdominal Injuries
Thoracic Injuries
High Energy Trauma
Keywords: robot-based tele-echography
tele-medicine
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: France Telecom R&D
First posted: 2006-02-23
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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 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.

Eligibility criteria: Inclusion Criteria:

* Person registered with the French Social Security or benefiting from an equivalent health insurance system
* Person sent to hospital for thoracoabdominal high energy trauma

Exclusion Criteria:

* Ward of court or under guardianship
* Adult unable to express their consent
* Person deprived of freedom by judicial or administrative decision
* Person hospitalized without their consent
* Person under legal protection
* Person participating in another clinical study

Primary outcomes:
measure: 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.
timeFrame: 6 month
Secondary outcomes:
measure: sensitivity, specificity, PPV, NPV are estimated with a 95% confidence interval
timeFrame: 6 month
measure: qualitative scores (including comfort and experience of the patient, quality of the echographic method evaluated by the physicians).
timeFrame: 6 month
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital
Study officials:
affiliation: Urgences Traumatologiques de l'hôpital SUD - Centre Hospitalier et Universitaire - Grenoble - B.P. 185 38042 GRENOBLE Cedex 09 - France
name: Jean-Jacques Banihachemi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vilchis A, Masuda K, Troccaz J, Cinquin P. Robot-based tele-echography: the TER system. Stud Health Technol Inform. 2003;95:212-7.