eFast Diagnosis Performance in Guiding First Aid Resuscitation (eFAST Decision)

February 7, 2022 updated by: University Hospital, Grenoble

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

510

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Cs10217
      • Grenoble, Cs10217, France, 38420
        • University Hospital of Grenoble Alpes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: Through study completion, an average of 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the duration of the initial lesion assessment by extended focused ultrasound (eFAST).
Time Frame: A Day 0
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).
Time Frame: Through study completion, an average of 1 year
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
Time Frame: during patient's care, at Hour 24 and at Day 8
Prognostic score ISS
during patient's care, at Hour 24 and at Day 8
Comparison of observed mortality and predicted mortality assessed by TRISS
Time Frame: during patient's care, at Hour 24 and at Day 8
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
Time Frame: during patient's care, at Hour 24 and at Day 8
Mortality evaluation
during patient's care, at Hour 24 and at Day 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Collaborators

Société Française d'Anesthésie et de Réanimation

Investigators

  • Principal Investigator: Pierre BOUZAT, University Hospital of Grenoble Alpes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 3, 2018

Primary Completion (Actual)

December 13, 2019

Study Completion (Actual)

January 21, 2020

Study Registration Dates

First Submitted

July 6, 2018

First Submitted That Met QC Criteria

October 5, 2018

First Posted (Actual)

October 9, 2018

Study Record Updates

Last Update Posted (Actual)

February 8, 2022

Last Update Submitted That Met QC Criteria

February 7, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC18.071
  • 2018-A00835-50 (Other Identifier: ID RCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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