Robot-based Tele-echography II - A Comparative Study

Thoracic Injuries Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00295438
• Other study ID #: DCIC 05 52
• Status: Terminated
• Phase: N/A
• First received: February 21, 2006
• Last updated: September 14, 2016
• Start date: February 2006
• Est. completion date: March 2009

Study information

• Verified date: September 2016
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: March 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Abdominal Injuries
• High Energy Trauma
• Thoracic Injuries
• Wounds and Injuries

Intervention

Device:
• Robot-Based Tele-Echography (TER)
Robot-Based Tele-Echography, ultrasound performed by the radiologist
• ultrasound method FAST
FAST,ultrasound performed by the emergency doctor

Locations

Country	Name	City	State
France	University Hospital	Grenoble

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Grenoble	France Telecom R&D

Country where clinical trial is conducted

France, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	sensitivity, specificity, PPV, NPV are estimated with a 95% confidence interval		6 month	No
Secondary	qualitative scores (including comfort and experience of the patient, quality of the echographic method evaluated by the physicians).		6 month	No

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