跳至主要内容
临床试验/NCT06104475
NCT06104475尚未招募不适用

Diagnostic Performance of Chest Computed Tomography Scan in Patients Aged 65 and Over Presenting to Emergency Room With Acute Dyspnea

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2023年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
240
试验地点
1
主要终点
Improved diagnosis

研究概览

简要总结

In acute dyspnea, the use of chest radiography is frequent and not very contributive, especially in the elderly patients.

However, early diagnosis of the cause of dyspnea in the ED is associated with a better prognosis, in particular for the identification of an infectious or cardiac origin.

Chest CT has already shown better diagnostic performances than conventional radiography in several pathologies such as low respiratory infection, and the development of so-called "low dose" scans allows to limit the irradiation during this examination.

The investigators aim to conduct a diagnostic study comparing non-injected chest CT-scan and conventional chest radiography in patients older than 65 presenting in the ED with acute dyspnea to assess whether CT-scan improves diagnosis.

详细描述

Patients of 65 years and older presenting to the emergency department with acute dyspnea and for whom a chest radiography is mandatory will be screened for inclusion. If the inclusion criteria are met and in the absence of non-inclusion criteria, free and informed oral consent will be sought.

Once the patient is included, management by the emergency physician will be routine.

A non-injected chest CT scan will be requested to the emergency radiology department in addition to the chest radiography. As a result, an X-ray and then a CT scan will be performed in each patient.

3 diagnoses will be collected:

  1. By the emergency physician in charge of the patient, after the chest X-ray and before the CT scan (DiagU1)
  2. By the emergency physician in charge of the patient, after the results of the scan (DiagU2)
  3. By an adjudication committee after review of the medical file (DiagExpert) A comparison will be made between the 3 diagnoses.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • •Age greater than or equal to 65 years
  • •Acute dyspnea (< 1 week)
  • •Prescription of a chest x-ray
  • •Oral free and informed consent of the patient after information and delivery of the information note
  • •Patient affiliated to a social security system

排除标准

  • •Inability to lie down
  • •Chest imaging done within the last 7 days
  • •Indication to perform a thoracic scan
  • •Patient under guardianship or curatorship
  • •Patient deprived of liberty, pregnant woman
  • •Participation in other interventional research

研究组 & 干预措施

CT scan intervention

Experimental

干预措施: CT scan (Other)

结局指标

主要结局

Improved diagnosis

时间窗: 28 days after inclusion

Proportion of patients with "bad diagnosis" before scanning and "good diagnosis" after scanning (according to adjudication committee)

次要结局

  • Improvement in diagnostic certainty(28 days after inclusion)
  • Discordant diagnosis(28 days after inclusion)
  • Scans performed(baseline (Day 0))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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