eFast Diagnosis Performance in Guiding First Aid Resuscitation

NCT ID: NCT03699670

Last Updated: 2022-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

510 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-03

Study Completion Date

2020-01-21

Brief Summary

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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.

Detailed Description

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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

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eFast Diagnosis Performance in Guiding First Aid Resuscitation and Hemostasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Société Française d'Anesthésie et de Réanimation

OTHER

Sponsor Role collaborator

University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre BOUZAT

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Grenoble Alpes

Locations

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University Hospital of Grenoble Alpes

Grenoble, Cs10217, France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 11810119 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21345104 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14734374 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15345974 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29288841 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15834704 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17325830 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26881977 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19926435 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7602628 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10528595 (View on PubMed)

Related Links

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Other Identifiers

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2018-A00835-50

Identifier Type: OTHER

Identifier Source: secondary_id

38RC18.071

Identifier Type: -

Identifier Source: org_study_id

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