NCT03699670

eFast Diagnosis Performance in Guiding First Aid Resuscitation

eFast Diagnosis Performance in Guiding First Aid Resuscitation at the Admission of Severe Trauma Injuries

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 510 (actual)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• eFast Diagnosis Performance in Guiding First Aid Resuscitation and Hemostasis

Timeline

• Start date: 2018-07-03
• Primary completion: 2019-12-13
• Completion: 2020-01-21
• First posted: 2018-10-09
• Last updated: 2022-02-08

Locations

1 site across 1 country: France