NCT00295438

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

February 21, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 23, 2006

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

September 15, 2016

Status Verified

September 1, 2016

Enrollment Period

2.9 years

First QC Date

February 21, 2006

Last Update Submit

September 14, 2016

Conditions

Abdominal InjuriesThoracic InjuriesHigh Energy Trauma

Keywords

robot-based tele-echographytele-medicine

Outcome Measures

Primary Outcomes (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.

    6 month

Secondary Outcomes (2)

  • sensitivity, specificity, PPV, NPV are estimated with a 95% confidence interval

    6 month

  • qualitative scores (including comfort and experience of the patient, quality of the echographic method evaluated by the physicians).

    6 month

Study Arms (2)

Robot-Based Tele-Echography (TER)

EXPERIMENTAL

ultrasound performed according to the method Tele-Echography

Device: Robot-Based Tele-Echography (TER)Device: ultrasound method FAST

ultrasound method FAST

ACTIVE COMPARATOR

ultrasound performed according to the method FAST (Focused Assessment Sonography for Trauma)

Device: Robot-Based Tele-Echography (TER)Device: ultrasound method FAST

Interventions

Robot-Based Tele-Echography (TER)DEVICE

Robot-Based Tele-Echography, ultrasound performed by the radiologist

Robot-Based Tele-Echography (TER)ultrasound method FAST
ultrasound method FASTDEVICE

FAST,ultrasound performed by the emergency doctor

Robot-Based Tele-Echography (TER)ultrasound method FAST

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Grenoble, 38000, France

Location

Related Publications (1)

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

    PMID: 14663989BACKGROUND

MeSH Terms

Conditions

Abdominal InjuriesThoracic Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Jean-Jacques Banihachemi, MD

    Urgences Traumatologiques de l'hôpital SUD - Centre Hospitalier et Universitaire - Grenoble - B.P. 185 38042 GRENOBLE Cedex 09 - France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2006

First Posted

February 23, 2006

Study Start

February 1, 2006

Primary Completion

January 1, 2009

Study Completion

March 1, 2009

Last Updated

September 15, 2016

Record last verified: 2016-09

Locations

FR(1)