Robot-Based Tele-Echography II - A Comparative Study - Tabular View

Tracking Information

First Received Date ^ICMJE

February 21, 2006

Last Updated Date

April 6, 2009

Start Date ^ICMJE

February 2006

Estimated Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

- 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.

Change History

Complete list of historical versions of study NCT00295438 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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).

Original Secondary Outcome Measures ^ICMJE

- 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).

Descriptive Information

Brief Title ^ICMJE

Robot-Based Tele-Echography II - A Comparative Study

Official Title ^ICMJE

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 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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study

Condition ^ICMJE

Abdominal Injuries
Thoracic Injuries
High Energy Trauma

Intervention ^ICMJE

Device: Robot-Based Tele-Echography : the TER system

Study Arms / Comparison Groups

Publications *

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

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

March 2009

Estimated Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00295438

Responsible Party

Jean-Jacques Banihachemi, University Hospital of Grenoble

Study ID Numbers ^ICMJE

DCIC 05 52

Study Sponsor ^ICMJE

University Hospital, Grenoble

Collaborators ^ICMJE

France Telecom R&D

Investigators ^ICMJE

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

Information Provided By

University Hospital, Grenoble

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP