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

Dyspnea Clinical Trial

— CT-Dys  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06104475
• Other study ID #: APHP220845
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2023
• Est. completion date: November 2024

Study information

• Verified date: October 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Yonathan FREUND, PU-PH
• Phone: 00 33 1 84 82 71 29
• Email: yonathan.freund[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: November 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyspnea
• Emergencies

Intervention

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

Locations

Country	Name	City	State
France	Emergency department Hospital Pitié-Salpêtrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improved diagnosis	Proportion of patients with "bad diagnosis" before scanning and "good diagnosis" after scanning (according to adjudication committee)	28 days after inclusion
Secondary	Discordant diagnosis	Proportion of patients with discordant pre- and post-scan diagnoses	28 days after inclusion
Secondary	Improvement in diagnostic certainty	Difference in "Diagnostic certainty" in percentage by self-assessment before and after scan	28 days after inclusion
Secondary	Scans performed	Proportion of patients for whom the scan was actually performed	baseline (Day 0)