NCT06104475

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 27, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

October 27, 2023

Status Verified

October 1, 2023

Enrollment Period

10 months

First QC Date

October 20, 2023

Last Update Submit

October 26, 2023

Conditions

Keywords

DyspneaEDChest CT-scan

Outcome Measures

Primary Outcomes (1)

  • Improved diagnosis

    Proportion of patients with "bad diagnosis" before scanning and "good diagnosis" after scanning (according to adjudication committee)

    28 days after inclusion

Secondary Outcomes (3)

  • Discordant diagnosis

    28 days after inclusion

  • Improvement in diagnostic certainty

    28 days after inclusion

  • Scans performed

    baseline (Day 0)

Study Arms (1)

CT scan intervention

EXPERIMENTAL
Other: CT scan

Interventions

CT scanOTHER

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

CT scan intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emergency department Hospital Pitié-Salpêtrière

Paris, 75013, France

Location

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yonathan FREUND, PU-PH

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yonathan FREUND, PU-PH

CONTACT

Judith GORLICKI, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2023

First Posted

October 27, 2023

Study Start

December 1, 2023

Primary Completion

October 1, 2024

Study Completion

November 1, 2024

Last Updated

October 27, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations