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

Not Applicable

Not yet recruiting

• Conditions: Dyspnea
• Interventions: Other: CT scan

• Registration Number: NCT06104475
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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 Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-10-20
• Study First Submitted QC: 2023-10-26
• Last Update Submitted: 2023-10-26
• Study First Posted: 2023-10-27
• Last Update Posted: 2023-10-27
• Study Start: 2023-12
• Primary Completion: 2024-10
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 240

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CT scan intervention	CT scan	-

Primary Outcome Measures

Name	Time	Method
Improved diagnosis	28 days after inclusion	Proportion of patients with "bad diagnosis" before scanning and "good diagnosis" after scanning (according to adjudication committee)

Secondary Outcome Measures

Name	Time	Method
Discordant diagnosis	28 days after inclusion	Proportion of patients with discordant pre- and post-scan diagnoses
Scans performed	baseline (Day 0)	Proportion of patients for whom the scan was actually performed
Improvement in diagnostic certainty	28 days after inclusion	Difference in "Diagnostic certainty" in percentage by self-assessment before and after scan

Trial Locations

Locations (1)

Emergency department Hospital Pitié-Salpêtrière; 🇫🇷 Paris, France