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Robot-based Tele-echography II - A Comparative Study

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ClinicalTrials.gov Identifier: NCT00295438
Recruitment Status : Terminated (No diagnosis of visceral lesion was placed on 18 included patients. The study is thus stopped prematurely for ethical reasons.)
First Posted : February 23, 2006
Last Update Posted : September 15, 2016
Sponsor:
Collaborator:
France Telecom R&D
Information provided by (Responsible Party):
University Hospital, Grenoble

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.

Condition or disease Intervention/treatment Phase
Abdominal Injuries Thoracic Injuries High Energy Trauma Device: Robot-Based Tele-Echography (TER) Device: ultrasound method FAST Not Applicable

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  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : February 2006
Actual Primary Completion Date : January 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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 ]

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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00295438


Locations
France
University Hospital
Grenoble, France, 38000
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

Publications:
Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT00295438     History of Changes
Other Study ID Numbers: DCIC 05 52
First Posted: February 23, 2006    Key Record Dates
Last Update Posted: September 15, 2016
Last Verified: September 2016

Keywords provided by University Hospital, Grenoble:
robot-based tele-echography
tele-medicine

Additional relevant MeSH terms:
Wounds and Injuries
Abdominal Injuries
Thoracic Injuries