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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A00835-50 | Other Identifier | ID RCB |
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| Name | Class |
|---|---|
| Société Française d'Anesthésie et de Réanimation | OTHER |
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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Retrospective assessment (on whole-body CT scans data and clinical data), by a panel of experts on the legitimacy of urgent therapeutic decisions taken, following the initial injury evaluation (among a pre-selection of decisions). Assessment of presence of pericardic, intra-abdominal or pleural effusion and presence of pubic symphisis. Assessment of physiological parameters of transcranial Doppler. | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the duration of the initial lesion assessment by extended focused ultrasound (eFAST). | Time measured between the arrival of the patient in the emergency room and the realization of immediate gestures of resuscitation and haemostasis | A Day 0 |
| Analysis of the main outcome measure in separate criterion: US (+/- Rx). |
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Inclusion Criteria:
Exclusion Criteria:
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All severe traumatized patients taken care in the emergency block of one of the investigator centers.
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| Name | Affiliation | Role |
|---|---|---|
| Pierre BOUZAT | University Hospital of Grenoble Alpes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Grenoble Alpes | Grenoble | Cs10217 | 38420 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11810119 | Background | Peytel E, Menegaux F, Cluzel P, Langeron O, Coriat P, Riou B. Initial imaging assessment of severe blunt trauma. Intensive Care Med. 2001 Nov;27(11):1756-61. doi: 10.1007/s00134-001-1119-z. Epub 2001 Oct 17. | |
| 21345104 | Background | Moore CL, Copel JA. Point-of-care ultrasonography. N Engl J Med. 2011 Feb 24;364(8):749-57. doi: 10.1056/NEJMra0909487. No abstract available. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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Analysis of the relevance of ultrasound vs X-rays by assessing the concordance rate between urgent therapeutic decisions and expert evaluations for each of the therapeutic modalities, taken separately |
| Through study completion, an average of 1 year |
| Comparison of observed mortality and predicted mortality assessed by ISS score | Prognostic score ISS | during patient's care, at Hour 24 and at Day 8 |
| Comparison of observed mortality and predicted mortality assessed by TRISS | Prognostic score TRISS | during patient's care, at Hour 24 and at Day 8 |
| Comparison of observed mortality and predicted mortality assessed by mortality evaluation | Mortality evaluation | during patient's care, at Hour 24 and at Day 8 |
| 14734374 | Background | Brooks A, Davies B, Smethhurst M, Connolly J. Emergency ultrasound in the acute assessment of haemothorax. Emerg Med J. 2004 Jan;21(1):44-6. doi: 10.1136/emj.2003.005438. |
| 15345974 | Background | Kirkpatrick AW, Sirois M, Laupland KB, Liu D, Rowan K, Ball CG, Hameed SM, Brown R, Simons R, Dulchavsky SA, Hamiilton DR, Nicolaou S. Hand-held thoracic sonography for detecting post-traumatic pneumothoraces: the Extended Focused Assessment with Sonography for Trauma (EFAST). J Trauma. 2004 Aug;57(2):288-95. doi: 10.1097/01.ta.0000133565.88871.e4. |
| 29288841 | Background | Geeraerts T, Velly L, Abdennour L, Asehnoune K, Audibert G, Bouzat P, Bruder N, Carrillon R, Cottenceau V, Cotton F, Courtil-Teyssedre S, Dahyot-Fizelier C, Dailler F, David JS, Engrand N, Fletcher D, Francony G, Gergele L, Ichai C, Javouhey E, Leblanc PE, Lieutaud T, Meyer P, Mirek S, Orliaguet G, Proust F, Quintard H, Ract C, Srairi M, Tazarourte K, Vigue B, Payen JF; French Society of Anaesthesia; Intensive Care Medicine; in partnership with Association de neuro-anesthesie-reanimation de langue francaise (Anarlf); French Society of Emergency Medicine (Societe Francaise de Medecine d'urgence (SFMU); Societe francaise de neurochirurgie (SFN); Groupe francophone de reanimation et d'urgences pediatriques (GFRUP); Association des anesthesistes-reanimateurs pediatriques d'expression francaise (Adarpef). Management of severe traumatic brain injury (first 24hours). Anaesth Crit Care Pain Med. 2018 Apr;37(2):171-186. doi: 10.1016/j.accpm.2017.12.001. Epub 2017 Dec 27. |
| 15834704 | Background | Jaffres P, Brun J, Declety P, Bosson JL, Fauvage B, Schleiermacher A, Kaddour A, Anglade D, Jacquot C, Payen JF. Transcranial Doppler to detect on admission patients at risk for neurological deterioration following mild and moderate brain trauma. Intensive Care Med. 2005 Jun;31(6):785-90. doi: 10.1007/s00134-005-2630-4. Epub 2005 Apr 16. |
| 17325830 | Background | Ract C, Le Moigno S, Bruder N, Vigue B. Transcranial Doppler ultrasound goal-directed therapy for the early management of severe traumatic brain injury. Intensive Care Med. 2007 Apr;33(4):645-51. doi: 10.1007/s00134-007-0558-6. Epub 2007 Feb 27. |
| 26881977 | Background | Shaukat NM, Copeli N, Desai P. The Focused Assessment With Sonography For Trauma (FAST) Examination And Pelvic Trauma: Indications And Limitations. Emerg Med Pract. 2016 Mar;18(3):1-20, 24; quiz 20-1. Epub 2016 Mar 1. |
| 19926435 | Background | Bauman M, Marinaro J, Tawil I, Crandall C, Rosenbaum L, Paul I. Ultrasonographic determination of pubic symphyseal widening in trauma: the FAST-PS study. J Emerg Med. 2011 May;40(5):528-33. doi: 10.1016/j.jemermed.2009.08.041. Epub 2009 Nov 17. |
| 7602628 | Background | Ma OJ, Mateer JR, Ogata M, Kefer MP, Wittmann D, Aprahamian C. Prospective analysis of a rapid trauma ultrasound examination performed by emergency physicians. J Trauma. 1995 Jun;38(6):879-85. doi: 10.1097/00005373-199506000-00009. |
| 10528595 | Background | Boulanger BR, McLellan BA, Brenneman FD, Ochoa J, Kirkpatrick AW. Prospective evidence of the superiority of a sonography-based algorithm in the assessment of blunt abdominal injury. J Trauma. 1999 Oct;47(4):632-7. doi: 10.1097/00005373-199910000-00005. |