Robot-based Tele-echography II - A Comparative Study

September 14, 2016 updated by: University Hospital, Grenoble

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.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38000
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Robot-Based Tele-Echography (TER)
ultrasound performed according to the method Tele-Echography
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
Active Comparator: ultrasound method FAST
ultrasound performed according to the method FAST (Focused Assessment Sonography for Trauma)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 6 month
6 month

Secondary Outcome Measures

Outcome Measure
Time Frame
sensitivity, specificity, PPV, NPV are estimated with a 95% confidence interval
Time Frame: 6 month
6 month
qualitative scores (including comfort and experience of the patient, quality of the echographic method evaluated by the physicians).
Time Frame: 6 month
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

February 21, 2006

First Submitted That Met QC Criteria

February 21, 2006

First Posted (Estimate)

February 23, 2006

Study Record Updates

Last Update Posted (Estimate)

September 15, 2016

Last Update Submitted That Met QC Criteria

September 14, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCIC 05 52

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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