Clinical trial NCT03699670: eFast Diagnosis Performance in Guiding First Aid Resuscitation
Official title: eFast Diagnosis Performance in Guiding First Aid Resuscitation at the Admission of Severe Trauma Injuries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: eFast Diagnosis Performance in Guiding First Aid Resuscitation and Hemostasis
Keywords: Resuscitation
Wounds and Injuries
Ultrasonography
Radiography
Diagnostic Imaging
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Société Française d'Anesthésie et de Réanimation
First posted: 2018-10-09
Enrollment: 510
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All severe traumatized patients taken care in the emergency block of one of the investigator centers.

Brief summary: A lesion work-up associating clinical examination, extended focused ultrasound (eFAST including abdominal ultrasound \[right upper, left upper, and suprapubic quadrant\], bilateral anterior and lateral pleuropulmonary ultrasound, sub-xyphoid pericardial ultrasound, transcranial Doppler), and possibly chest and pelvis x-ray, can early diagnose the most severe traumatic lesions and guide first aid resuscitation and haemostasis. The protocol does not modify the diagnostic and therapeutic strategies applied in the participant centers.

The objective of the study is to evaluate the diagnosis performance of an initial lesion assessment by extended focused ultrasound (eFAST) (possibly associated with chest and pelvis x-ray) at the early phase of a severe trauma patient care in guiding first aid resuscitation and haemostasis.

The relevance will be judged on the therapeutic decisions taken (thoracic or pericardial drainage, thoracotomy or laparotomy, pelvic embolization, posture of a pelvic girdle, and early optimization of cerebral perfusion pressure) based on the initial ultrasound scan.

Detailed description: Some of the severe traumatized patients who arrive alive in the hospital, are in serious hemodynamic and / or respiratory instability and need resuscitation and / or hemostasis immediate act before a complete exhaustive work-up can be realized. Usually this is a whole body CT scan. These gestures are guided by imaging examinations (extensive focused ultrasound \[eFAST\] +/- chest X-ray +/- pelvis X-ray) which are less accurate but faster at the patient's bedside. The ability of extended focused ultrasound to properly guide immediate resuscitation and hemostasis should be evaluated to assess effectiveness and safety of the method.

This trial is a national prospective cohort (6 French centers). Each participant will benefit from an initial lesion work-up by clinical examination, followed by an extended focused ultrasound (eFAST including abdominal ultrasound \[right upper, left upper, and suprapubic quadrant\], bilateral anterior and lateral pleuropulmonary ultrasound, sub-xyphoid pericardial ultrasound, transcranial Doppler), and possibly chest and pelvis frontal x-ray.

Based on clinical, radiographic and ultrasound data, the investigator will decide to perform immediate resuscitation and haemostasis gestures, or therapeutic abstention, before the realization of the complete lesion work-up by whole body CT scan.

This study could validate and strengthen the place of ultrasound in the initial severe traumatic patients' care and seems to be the continuity of the Peytel et al. research, studying new modalities of the eFAST. Our study could extend the scope and the conclusions of the Peytel et al. study to what is routinely done in the French and European Trauma Centers.

Eligibility criteria: Inclusion Criteria:

* Serious trauma (Grade A or B according to the TRENAU classification)
* In the emergency room of an investigator center

Exclusion Criteria:

* Patient died on site or on arrival at the emergency room
* Patient with penetrating trauma
* Patient admitted to another center and then transferred to an investigator center
* Patient referred to in Articles L1121-5 to L1121-8 of the French Code of Public Health (pregnant, parturient, breastfeeding woman, person deprived of liberty, person under legal protection).

Primary outcomes:
measure: Evaluation of the diagnosis performance of an initial lesion assessment by extended focused ultrasound (eFAST) at the early phase of a severe trauma patient care in guiding first aid resuscitation and haemostasis.
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Evaluation of the duration of the initial lesion assessment by extended focused ultrasound (eFAST).
timeFrame: A Day 0
measure: Analysis of the main outcome measure in separate criterion: US (+/- Rx).
timeFrame: Through study completion, an average of 1 year
measure: Comparison of observed mortality and predicted mortality assessed by ISS score
timeFrame: during patient's care, at Hour 24 and at Day 8
measure: Comparison of observed mortality and predicted mortality assessed by TRISS
timeFrame: during patient's care, at Hour 24 and at Day 8
measure: Comparison of observed mortality and predicted mortality assessed by mortality evaluation
timeFrame: during patient's care, at Hour 24 and at Day 8
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital of Grenoble Alpes
state: Cs10217
Study officials:
affiliation: University Hospital of Grenoble Alpes
name: Pierre BOUZAT
role: PRINCIPAL_INVESTIGATOR
References:
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