Clinical trial NCT06104475: Diagnostic Performance of Chest Computed Tomography Scan in Patients Aged 65 and Over Presenting to Emergency Room With Acute Dyspnea
Official title: Diagnostic Performance of Chest Computed Tomography Scan in Patients Aged 65 and Over Presenting to Emergency Room With Acute Dyspnea
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dyspnea
Keywords: Dyspnea
ED
Chest CT-scan
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-10-27
Enrollment: 240
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Improved diagnosis
timeFrame: 28 days after inclusion
Secondary outcomes:
measure: Discordant diagnosis
timeFrame: 28 days after inclusion
measure: Improvement in diagnostic certainty
timeFrame: 28 days after inclusion
measure: Scans performed
timeFrame: baseline (Day 0)
Other outcomes:
Locations:
city: Paris
country: France
facility: Emergency department Hospital Pitié-Salpêtrière
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Yonathan FREUND, PU-PH
role: PRINCIPAL_INVESTIGATOR
References: