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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dyspnea
• Intervention / Treatment: Other: CT scan

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 Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yonathan FREUND, PU-PH; Phone Number: 00 33 1 84 82 71 29; Email: yonathan.freund@aphp.fr
• Study Contact Backup: Name: Judith GORLICKI, MD; Phone Number: 0676871142; Email: Judith.gorlicki@aphp.fr

Study Locations

• France
  • Paris, France, 75013
    • Emergency department Hospital Pitié-Salpêtrière

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CT scan intervention	Other: CT scan; A CT scan will be requested for every patient in addition to the chest X-ray

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improved diagnosis	Proportion of patients with "bad diagnosis" before scanning and "good diagnosis" after scanning (according to adjudication committee)	28 days after inclusion

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Yonathan FREUND, PU-PH, Assistance Publique - Hopitaux de Paris

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: October 20, 2023
• First Submitted That Met QC Criteria: October 26, 2023
• First Posted (Actual): October 27, 2023

Study Record Updates

• Last Update Posted (Actual): October 27, 2023
• Last Update Submitted That Met QC Criteria: October 26, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: ED; Dyspnea; Chest CT-scan
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Disease Attributes; Signs and Symptoms, Respiratory; Emergencies; Dyspnea
• Other Study ID Numbers: APHP220845

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No