Robot-based Tele-echography II - A Comparative Study

Grenoble Alpes University Hospital Center (CHU)

Status: Terminated

Conditions: Abdominal Injuries; High Energy Trauma; Thoracic Injuries

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00295438

DCIC 05 52

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Robot-Based Tele-Echography (TER)

Experimental group

Description:

ultrasound performed according to the method Tele-Echography

Treatment:

Device: Robot-Based Tele-Echography (TER)

Device: ultrasound method FAST

ultrasound method FAST

Active Comparator group

Description:

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

Treatment:

Device: Robot-Based Tele-Echography (TER)

Device: ultrasound method FAST