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

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06104475
Collaborator
(none)
240
1
1
11
21.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: CT scan
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
240 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Diagnostic Performance of Chest Computed Tomography Scan in Patients Aged 65 and Over Presenting to Emergency Room With Acute Dyspnea
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Nov 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Discordant diagnosis [28 days after inclusion]

    Proportion of patients with discordant pre- and post-scan diagnoses

  2. Improvement in diagnostic certainty [28 days after inclusion]

    Difference in "Diagnostic certainty" in percentage by self-assessment before and after scan

  3. Scans performed [baseline (Day 0)]

    Proportion of patients for whom the scan was actually performed

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Emergency department Hospital Pitié-Salpêtrière Paris France 75013

Sponsors and Collaborators

  • Assistance Publique - Hôpitaux de Paris

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT06104475
Other Study ID Numbers:
  • APHP220845
First Posted:
Oct 27, 2023
Last Update Posted:
Oct 27, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Assistance Publique - Hôpitaux de Paris
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 27, 2023