eFast Diagnosis Performance in Guiding First Aid Resuscitation and Hemostasis Clinical Trial
— eFAST DecisionOfficial title:
eFast Diagnosis Performance in Guiding First Aid Resuscitation at the Admission of Severe Trauma Injuries
| Verified date | February 2022 |
| Source | University Hospital, Grenoble |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 510 |
| Est. completion date | January 21, 2020 |
| Est. primary completion date | December 13, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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). |
| Country | Name | City | State |
|---|---|---|---|
| France | University Hospital of Grenoble Alpes | Grenoble | Cs10217 |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Grenoble | Société Française d'Anesthésie et de Réanimation |
France,
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. — View Citation
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. — View Citation
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. — View Citation
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, Gergelé L, Ichai C, Javouhey É, Leblanc PE, Lieutaud T, Meyer P, Mirek S, Orliaguet G, Proust F, Quintard H, Ract C, Srairi M, Tazarourte K, Vigué B, Payen JF; French Society of Anaesthesia; Intensive Care Medicine; in partnership with Association de neuro-anesthésie-réanimation de langue française (Anarlf); French Society of Emergency Medicine (Société Française de Médecine d'urgence (SFMU); Société française de neurochirurgie (SFN); Groupe francophone de réanimation et d'urgences pédiatriques (GFRUP); Association des anesthésistes-réanimateurs pédiatriques d'expression française (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. Review. — View Citation
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. Epub 2005 Apr 16. — View Citation
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. — View Citation
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. — View Citation
Moore CL, Copel JA. Point-of-care ultrasonography. N Engl J Med. 2011 Feb 24;364(8):749-57. doi: 10.1056/NEJMra0909487. Review. — View Citation
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. Epub 2001 Oct 17. — View Citation
Ract C, Le Moigno S, Bruder N, Vigué 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. Epub 2007 Feb 27. — View Citation
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. Review. — View Citation
* Note: There are 11 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Secondary | 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 | |
| Secondary | Analysis of the main outcome measure in separate criterion: US (+/- Rx). | 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 | |
| Secondary | 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 | |
| Secondary | Comparison of observed mortality and predicted mortality assessed by TRISS | Prognostic score TRISS | during patient's care, at Hour 24 and at Day 8 | |
| Secondary | Comparison of observed mortality and predicted mortality assessed by mortality evaluation | Mortality evaluation | during patient's care, at Hour 24 and at Day 8 |