Skip to main content
OpenTrials
Completed

NCT Number: NCT05897476

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire de Besancon

Besançon, 25030, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ultrasound

Other

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

Primary outcomes

  1. Successful completion of FESDAU protocol.

    Time frame: 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 outcomes

  1. time to diagnosis

    Time frame: 24 hours

    time to diagnosis with FESDAU protocol

  2. Time to perform the ultrasound

    Time frame: 60 minutes

    during of processing ultrasound

  3. Ultrasound slices with a suggestive sign

    Time frame: 60 minutes

    wich slices are the most interesting

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Acronym: FESDAU

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 9, 2023
Registry last updated
Dec 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.