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

Sponsor

Centre Hospitalier Universitaire de Besancon (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05897476

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

4.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Dissection Emergency Ultrasound	Other: ultrasound	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention 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.Prospective single-center interventional diagnosticH1: 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)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ultrasound arm every patient will be examine with ultrasound	Other: ultrasound brief external ultrasound will be proceed on each patient included searching signs of aortic dissection

Arm

Intervention/Treatment

Experimental: ultrasound arm

every patient will be examine with ultrasound

Other: ultrasound

brief external ultrasound will be proceed on each patient included searching signs of aortic dissection

Outcome Measures

Primary Outcome Measures

Successful completion of FESDAU protocol. [15 minutes]
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 [24 hours]
time to diagnosis with FESDAU protocol
Time to perform the ultrasound [60 minutes]
during of processing ultrasound
Ultrasound slices with a suggestive sign [60 minutes]
wich slices are the most interesting

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 95 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier Universitaire de Besancon	Besançon		France	25030

Sponsors and Collaborators

Centre Hospitalier Universitaire de Besancon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Besancon

ClinicalTrials.gov Identifier:

NCT05897476

Other Study ID Numbers:

2023/781

First Posted:

Jun 9, 2023

Last Update Posted:

Jun 9, 2023

Last Verified:

May 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Aortic Dissection

Emergencies

Study Results

No Results Posted as of Jun 9, 2023