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Clinical Trials/NCT06104475
NCT06104475Not yet recruitingNot Applicable

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

Assistance Publique - Hôpitaux de Paris2 sites in 1 country240 target enrollmentStarted: December 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
240
Locations
2
Primary Endpoint
Improved diagnosis

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Improved diagnosis

Time Frame: 28 days after inclusion

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

Secondary Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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