Robot-Based Tele-Echography II - A Comparative Study - Full Text View

Purpose

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.

Condition	Intervention
Abdominal Injuries Thoracic Injuries High Energy Trauma	Device: Robot-Based Tele-Echography : the TER system

MedlinePlus related topics:

Injuries Ultrasound Wounds

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy 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.

Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

sensitivity, specificity, PPV, NPV are estimated with a 95% confidence interval
qualitative scores (including comfort and experience of the patient, quality of the echographic method evaluated by the physicians).

Estimated Enrollment:	70
Study Start Date:	February 2006
Estimated Study Completion Date:	August 2006

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00295438

Contacts


Contact: Jean-Jacques Banihachemi, MD		JJBanihachemi@chu-grenoble.fr

Contact: Alexandre Moreau-Gaudry, MD PhD		AMoreau-Gaudry@chu-grenoble.fr

Locations


France
	University Hospital	Recruiting
	Grenoble, France, 38000
	Contact: Jean-Jacques Banihachemi, MD 33 4 76 76 54 23 JJBanihachemi@chu-grenoble.fr
	Contact: Alexandre Moreau-Gaudry, MD PhD 33 4 76 76 92 60 AMoreau-Gaudry@chu-grenoble.fr
	Sub-Investigator: Alexandre Moreau-Gaudry, MD PhD
	Sub-Investigator: Ivan Bricault, MD PhD
	Principal Investigator: Jean-Jacques Banihachemi, MD
	Sub-Investigator: Jean-Luc Bosson, MD PhD

Sponsors and Collaborators

University Hospital, Grenoble

France Telecom R&D

Investigators


Principal Investigator:	Jean-Jacques Banihachemi, MD	Urgences Traumatologiques de l'hôpital SUD - Centre Hospitalier et Universitaire - Grenoble – B.P. 185 38042 GRENOBLE Cedex 09 - France

More Information

Publications:

Vilchis A, Masuda K, Troccaz J, Cinquin P. Robot-based tele-echography: the TER system. Stud Health Technol Inform. 2003;95:212-7.

Study ID Numbers:	DCIC 05 52
First Received:	February 21, 2006
Last Updated:	July 5, 2006
ClinicalTrials.gov Identifier:	NCT00295438
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Grenoble:

robot-based tele-echography

tele-medicine

Study placed in the following topic categories:

Thoracic Injuries

Wounds and Injuries

Disorders of Environmental Origin

Abdominal Injuries

ClinicalTrials.gov processed this record on October 29, 2008

Sponsors and Collaborators:	University Hospital, Grenoble France Telecom R&D
Information provided by:	University Hospital, Grenoble
ClinicalTrials.gov Identifier:	NCT00295438