eFast Diagnosis Performance in Guiding First Aid Resuscitation

NCT03699670 | Completed

• 2 other identifiers: 38RC18.0712018-A00835-50
• Study Type: observational
• Target: 510
• Locations: 1 country
• Sites: 1

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.

Conditions

eFast Diagnosis Performance in Guiding First Aid Resuscitation and Hemostasis

Keywords

Resuscitation; Wounds and Injuries; Ultrasonography; Radiography; Diagnostic Imaging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Evaluation of the duration of the initial lesion assessment by extended focused ultrasound (eFAST).

  A Day 0

• Analysis of the main outcome measure in separate criterion: US (+/- Rx).

  Through study completion, an average of 1 year

• Comparison of observed mortality and predicted mortality assessed by ISS score

  during patient's care, at Hour 24 and at Day 8

• Comparison of observed mortality and predicted mortality assessed by TRISS

  during patient's care, at Hour 24 and at Day 8

• Comparison of observed mortality and predicted mortality assessed by mortality evaluation

  during patient's care, at Hour 24 and at Day 8

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All severe traumatized patients taken care in the emergency block of one of the investigator centers.

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Société Française d'Anesthésie et de Réanimation: collaborator

Study Sites (1)

University Hospital of Grenoble Alpes

Grenoble, Cs10217, 38420, France

Location

Related Publications (11)

• 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.

  PMID: 11810119 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.

  PMID: 21345104 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.

  PMID: 14734374 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.

  PMID: 15345974 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.

  PMID: 29288841 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.

  PMID: 15834704 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.

  PMID: 17325830 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.

  PMID: 26881977 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.

  PMID: 19926435 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.

  PMID: 7602628 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.

  PMID: 10528595 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Pierre BOUZAT

  University Hospital of Grenoble Alpes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2018
• First Posted: October 9, 2018
• Study Start: July 3, 2018
• Primary Completion: December 13, 2019
• Study Completion: January 21, 2020
• Last Updated: February 8, 2022

Record last verified: 2022-02

Locations

FR (1)