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Prospective Feasibility Study of Point-of-care Ultrasound in Suspected Aortic Dissection (FESDAU)

Primary Purpose

Aortic Dissection, Emergency Ultrasound

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ultrasound
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Aortic Dissection

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Men and women aged 18-95 years included Non-opposition of the subject to participate in the study All patients admitted to the emergency department of the Besançon University Hospital With chest, abdominal, back, lumbar pain, or acute headache AORTA score ≥ 1 Clinical suspicion of AD by the emergency physician Exclusion Criteria: Legal incapacity or limited legal capacity Subject unlikely to cooperate with the study and/or poor cooperation anticipated by the investigator Subject without health insurance Pregnant woman ECG showing acute coronary syndrome and/or ventricular rhythm disturbances Traumatic context, or traumatic cause of pain Chronic / subacute dissection (patient with incidental discovery of aortic dissection (city assessment) and then referred to the emergency room). Patient refusal to participate in the study

Sites / Locations

  • Centre Hospitalier Universitaire de Besancon

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ultrasound arm

Arm Description

every patient will be examine with ultrasound

Outcomes

Primary Outcome Measures

Successful completion of FESDAU protocol.
The statistical analysis on the primary endpoint will be a percentage of success in completing the FESDAU protocol among all eligible individuals.

Secondary Outcome Measures

time to diagnosis
time to diagnosis with FESDAU protocol
Time to perform the ultrasound
during of processing ultrasound
Ultrasound slices with a suggestive sign
wich slices are the most interesting

Full Information

First Posted
May 26, 2023
Last Updated
June 7, 2023
Sponsor
Centre Hospitalier Universitaire de Besancon
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1. Study Identification

Unique Protocol Identification Number
NCT05897476
Brief Title
Prospective Feasibility Study of Point-of-care Ultrasound in Suspected Aortic Dissection
Acronym
FESDAU
Official Title
Prospective Feasibility Study of Point-of-care Ultrasound in Suspected Aortic Dissection
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Aortic dissection is an uncommon and serious pathology. Its diagnosis is difficult because of the varied and silent clinical presentations. The development of ultrasound in emergency medicine is an asset in certain pathologies. The aim of this study is therefore to study the feasibility of a protocol integrating clinical ultrasound in the suspicion of acute aortic dissection in the hospital setting. This study is a single-center prospective interventional study. In which the investigators perform ultrasound in patients with suspected acute aortic dissection in the emergency department. If the protocol is feasible and if it allows a saving of time in the diagnosis or an increase in diagnoses, the investigators will be able to evoke a profitability to the systematic realization of this examination.
Detailed Description
H0: patient selection and inclusion: Presentation of the study Delivery of the information note / no objection to the patient if he/she is in a state to consent Emergency procedure: In accordance with article L-1122-1-3 of the public health code, patients may be included in the study at the initiative of the physician without seeking prior consent. This procedure will be associated with a prior call to the relatives to obtain an oral consent in principle (traced in the patient's medical file), while waiting for the delivery of the information note / no objection to the relatives and then to the patient as soon as his condition allows it. H1: inclusion interview then : Medical interrogation (retrospective collection if already done / but additional requests if missing data). Clinical examination (complementary if missing data). Ultrasound with 3 ultrasound sections to be performed: parasternal long axis, supra-sternal and abdominal, looking for the following signs: Direct signs: presence of an intimal flap, intramural aortic hematoma > 5mm, penetrating aortic ulcer. Indirect signs: pericardial effusion, aortic dilatation ≥ 4 cm, tamponade (1). H4: retrospective collection of the results of complementary examinations if any, biological and radiological, and collection of the final diagnosis retained.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Dissection, Emergency Ultrasound

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective single-center interventional diagnostic H1: inclusion interview then : Medical interrogation (retrospective collection if already done / but additional requests if missing data). Clinical examination (complementary if missing data). Ultrasound with 3 ultrasound sections to be performed: parasternal long axis, supra-sternal and abdominal, looking for the following signs: Direct signs: presence of an intimal flap, intramural aortic hematoma > 5mm, penetrating aortic ulcer. Indirect signs: pericardial effusion, aortic dilatation ≥ 4 cm, tamponade (1). H4: retrospective collection of the results of complementary examinations if any, biological and radiological, and collection of the final diagnosis retained.
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ultrasound arm
Arm Type
Experimental
Arm Description
every patient will be examine with ultrasound
Intervention Type
Other
Intervention Name(s)
ultrasound
Intervention Description
brief external ultrasound will be proceed on each patient included searching signs of aortic dissection
Primary Outcome Measure Information:
Title
Successful completion of FESDAU protocol.
Description
The statistical analysis on the primary endpoint will be a percentage of success in completing the FESDAU protocol among all eligible individuals.
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
time to diagnosis
Description
time to diagnosis with FESDAU protocol
Time Frame
24 hours
Title
Time to perform the ultrasound
Description
during of processing ultrasound
Time Frame
60 minutes
Title
Ultrasound slices with a suggestive sign
Description
wich slices are the most interesting
Time Frame
60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Men and women aged 18-95 years included Non-opposition of the subject to participate in the study All patients admitted to the emergency department of the Besançon University Hospital With chest, abdominal, back, lumbar pain, or acute headache AORTA score ≥ 1 Clinical suspicion of AD by the emergency physician Exclusion Criteria: Legal incapacity or limited legal capacity Subject unlikely to cooperate with the study and/or poor cooperation anticipated by the investigator Subject without health insurance Pregnant woman ECG showing acute coronary syndrome and/or ventricular rhythm disturbances Traumatic context, or traumatic cause of pain Chronic / subacute dissection (patient with incidental discovery of aortic dissection (city assessment) and then referred to the emergency room). Patient refusal to participate in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christian DAGUERRE, MD
Phone
+33381668853
Email
daguerrechristian@laposte.net
First Name & Middle Initial & Last Name or Official Title & Degree
Noémie NMINEJ
Phone
+33381218518
Email
nnminej@chu-besancon.fr
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Besancon
City
Besançon
ZIP/Postal Code
25030
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian DAGUERRE, MD
Phone
+33381668853
Email
daguerrechristian@laposte.net

12. IPD Sharing Statement

Learn more about this trial

Prospective Feasibility Study of Point-of-care Ultrasound in Suspected Aortic Dissection

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