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临床试验/NCT07037797
NCT07037797尚未招募不适用

Phased-Array Versus Curvilinear Probe for FAST Ultrasonography

Centre Hospitalier Memorial France Etats-Unis0 个研究点目标入组 2,660 人开始时间: 2025年7月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
2,660
主要终点
Diagnostic performance

研究概览

简要总结

Background:

FAST ultrasound is a crucial technique in emergency medicine, enabling rapid assessment of trauma patients.

By allowing visualization of an effusion in a trauma patient in a far more sensitive and specific way than clinical examination, it enables informed decisions to be made on therapeutics, technical gestures, but also the potential receiving service.

Arbitrarily, FAST ultrasound is taught with the cardiac probe (phased-array) and the abdominal probe (curvilinear). The difference in use of these two probes varies according to operator and team, with no figures available.

No recent study has been conducted on the possibility of better diagnostic performance of FAST with a curvilinear versus phased-array probe.

Objective:

The main objective of this project is to evaluate and compare the diagnostic performance of FAST ultrasound using a phased-array probe versus a curvilinear probe in the detection of effusions in trauma patients (FAST protocol).

Materials and methods:

Prospective, interventional, multicenter, randomized study.

Hypothesis tested:

FAST-ultrasound with a curvilinear probe improves diagnostic performance compared with FAST-ultrasound with a phased-array probe.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Trauma patients attending emergency departments in investigating centers
  • Age ≥ 18 years
  • Indication retained for FAST-ultrasound by the emergency physician in charge of the patient
  • Patient affiliated to the French Social Security system or equivalent

排除标准

  • Patients undergoing treatment limitation or discontinuation
  • Pregnant, parturient or breast-feeding women
  • Patients deprived of liberty by judicial or administrative decision

结局指标

主要结局

Diagnostic performance

时间窗: From inclusion to the CT-scan results (which is the gold standard)

Diagnostic performance with sensitivity and specificity calculations for the 'curvilinear' probe and the 'phased-array' probe in the detection of an effusion in trauma patients (FAST protocol).

次要结局

  • Performance time(During the FAST echography)
  • Professional experience in FAST echography(After its first inclusion)
  • Previous experience in FAST echography(After its first inclusion)
  • Diagnostic performance according to the area(After the CT-scan results (which is the gold standard))

研究者

发起方
Centre Hospitalier Memorial France Etats-Unis
申办方类型
Other
责任方
Sponsor

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