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

NCT05897476 | Completed

• 1 other identifier: 2023/781
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Dissection; Emergency Ultrasound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• time to diagnosis

  24 hours

• Time to perform the ultrasound

  60 minutes

• Ultrasound slices with a suggestive sign

  60 minutes

Study Arms (1)

ultrasound arm

EXPERIMENTAL

every patient will be examine with ultrasound

Other: ultrasound

Interventions

ultrasound OTHER

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

ultrasound arm

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

Centre Hospitalier Universitaire de Besancon

Besançon, 25030, France

Location

MeSH Terms

Conditions

Aortic Dissection

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Design

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

Model Details: 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.

Study Record Dates

• First Submitted: May 26, 2023
• First Posted: June 9, 2023
• Study Start: September 8, 2023
• Primary Completion: December 24, 2023
• Study Completion: December 25, 2023
• Last Updated: December 31, 2024

Record last verified: 2023-05

Locations

FR (1)