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

NCT ID: NCT05897476

Last Updated: 2024-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-08

Study Completion Date

2023-12-25

Brief Summary

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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

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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.

Conditions

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Aortic Dissection Emergency Ultrasound

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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ultrasound arm

every patient will be examine with ultrasound

Group Type EXPERIMENTAL

ultrasound

Intervention Type OTHER

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

Interventions

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ultrasound

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Hospitalier Universitaire de Besancon

Besançon, , France

Site Status

Countries

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France

Other Identifiers

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2023/781

Identifier Type: -

Identifier Source: org_study_id