Diagnostic Performance of Chest Computed Tomography Scan... | NCT06104475

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

NCT06104475

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Unknown status

Last Update Posted

Oct 27, 2023Actual

Enrollment

240Estimated

Phase

Not Applicable

Conditions

Dyspnea

Interventions

CT scan

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2023Estimated

Primary Completion Date

Oct 2024Estimated

Completion Date

Nov 2024Estimated

First Submitted Date

Oct 20, 2023

First Submission Date that Met QC Criteria

Oct 26, 2023

First Posted Date

Oct 27, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 26, 2023

Last Update Posted Date

Oct 27, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

By the emergency physician in charge of the patient, after the chest X-ray and before the CT scan (DiagU1)
By the emergency physician in charge of the patient, after the results of the scan (DiagU2)
By an adjudication committee after review of the medical file (DiagExpert) A comparison will be made between the 3 diagnoses.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

240Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CT scan intervention	Experimental		Other: CT scan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CT scan	Other	A CT scan will be requested for every patient in addition to the chest X-ray	CT scan intervention

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yonathan FREUND, PU-PH	Contact	00 33 1 84 82 71 29		yonathan.freund@aphp.fr
Judith GORLICKI, MD	Contact	0676871142		Judith.gorlicki@aphp.fr

Overall Officials

Name	Affiliation	Role
Yonathan FREUND, PU-PH	Assistance Publique - Hôpitaux de Paris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Emergency department Hospital Pitié-Salpêtrière		Paris		75013	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004417	Dyspnea

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided