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

Aortic Dissection Clinical Trial

— FESDAU  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05897476
• Other study ID #: 2023/781
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2023
• Est. completion date: June 2024

Study information

• Verified date: May 2023
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Christian DAGUERRE, MD
• Phone: +33381668853
• Email: daguerrechristian[@]laposte.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: June 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Aortic Dissection
• Emergencies
• Emergency Ultrasound

Intervention

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

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Besancon	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	15 minutes
Secondary	time to diagnosis	time to diagnosis with FESDAU protocol	24 hours
Secondary	Time to perform the ultrasound	during of processing ultrasound	60 minutes
Secondary	Ultrasound slices with a suggestive sign	wich slices are the most interesting	60 minutes