Optimization of the Diagnosis of Bone FRACtures in Patients Treated in the Emergency Department by Using Artificial Intelligence for Reading Radiological Images in Comparison With Traditional Reading by the Emergency Doctor.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,500
- 试验地点
- 2
- 主要终点
- Patient readmission rate for failure to diagnose fracture during initial treatment.
研究概览
简要总结
As part of the management of a patient with suspected bone fractures, emergency physicians are required to make treatment decisions before obtaining the imaging reading report from the radiologist, who is generally not available only a few hours after the patient's admission, or even the following day. This situation of the emergency doctor, alone interpreting the radiological image, in a context of limited time due to the large flow of patients to be treated, leads to a significant risk of interpretation error. Unrecognized fractures represent one of the main causes of diagnostic errors in emergency departments.
This comparative study consists of two cohorts of patients referred to the emergency department for suspected bone fracture. The first will be of interest to patients whose radiological images will be interpreted by the reading of the emergency doctor systematically doubled by the reading of the artificial intelligence. The other will interest a group of patients cared for by the simple reading of the emergency doctor.
All of the images from both groups of patients will be re-read by the establishment's group of radiologists no later than 24 hours following the patient's treatment.
A centralized review will be provided by two expert radiologists. Also, patients in both groups will be systematically recalled in the event of detection of an unknown fracture for hospitalization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 否
入选标准
- •Major Subject
- •Patient admitted to the emergency department for suspected peripheral fractures in the extremities of the upper limb and/or lower limb (wrist/hand and ankle/foot).
- •Patient affiliated to or entitled to a social security system
- •Patient having received written and informed information about the study and having signed a free and informed consent to participate in the study.
排除标准
- •Patient previously admitted to the emergency room for suspicion of fractures and not included in the study
- •Patient admitted to the emergency room with suspicion of multiple fractures
- •Refusal to participate in the study
- •Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision and under judicial protection
- •Pregnant, breastfeeding or parturient patient
结局指标
主要结局
Patient readmission rate for failure to diagnose fracture during initial treatment.
时间窗: 1 day
This rate will be determined in each group (reading by the emergency doctor systematically doubled by the reading of the AI vs. simple reading by the emergency doctor) compared to centralized rereading.
次要结局
未报告次要终点