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

NCT ID: NCT06104475

Last Updated: 2023-10-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-31
• Study Completion Date: 2024-11-30

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.

Conditions

Dyspnea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

CT scan intervention

Group Type: EXPERIMENTAL

CT scan

Intervention Type: OTHER

A CT scan will be requested for every patient in addition to the chest X-ray

Interventions

CT scan

A CT scan will be requested for every patient in addition to the chest X-ray

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yonathan FREUND, PU-PH

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Emergency department Hospital Pitié-Salpêtrière

Paris, , France

Countries

France

Central Contacts

Yonathan FREUND, PU-PH

Role: CONTACT

yonathan.freund@aphp.fr

00 33 1 84 82 71 29

Judith GORLICKI, MD

Role: CONTACT

Judith.gorlicki@aphp.fr

0676871142

Other Identifiers

APHP220845

Identifier Type: -

Identifier Source: org_study_id