Diagnostic Value of Portable Ultrasound for Dyspneic Patient Support in the Emergency Department

NCT ID: NCT01818882

Last Updated: 2016-04-06

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

TERMINATED

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-01-31

Brief Summary

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The main objective of our study is to compare the effects of two care strategies for dyspneic patients on the length of hospital stay: (1) standard care (=contextual analysis + conventional clinical chest radiography) versus (2) standard care + pleuropulmonary ultrasound.

Detailed Description

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The secondary objectives of this study are to assess the following for both arms:

A-fatality rate, B-degree of concordance between the diagnosis orientation in the emergency department and final diagnosis determined by an expert committee using patient records one month later (blind evaluation by a panel of experts) C-clinical improvement between early emergency care and later care outside the emergency department (clinical parameters = blood gases and other biological parameters) D-imaging parameters.

Conditions

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Dyspnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Standard care

Patients randomized to this arm will receive standard care.

Intervention: Standard care.

Group Type ACTIVE_COMPARATOR

Standard care

Intervention Type OTHER

Standard care for dyspneic patients including contextual analysis, conventional clinical exam and a chest X-Ray.

Standard care + ultrasound

Patients randomized to this arm will receive standard care + pleuropulmonary ultrasound.

Intervention: Standard care + ultrasound

Group Type EXPERIMENTAL

Standard care

Intervention Type OTHER

Standard care for dyspneic patients including contextual analysis, conventional clinical exam and a chest X-Ray.

Vscan portable ultrasound device (GE Healthcare, Wauwatosa, WI)

Intervention Type DEVICE

Standard care (as described for the other intervention) + pleuropulmonary ultrasound using the Vscan portable ultrasound device (GE Healthcare, Wauwatosa, WI).

Interventions

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Standard care

Standard care for dyspneic patients including contextual analysis, conventional clinical exam and a chest X-Ray.

Intervention Type OTHER

Vscan portable ultrasound device (GE Healthcare, Wauwatosa, WI)

Standard care (as described for the other intervention) + pleuropulmonary ultrasound using the Vscan portable ultrasound device (GE Healthcare, Wauwatosa, WI).

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* Patient consulting in the emergency department for dyspnea

Exclusion Criteria

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient cannot read French
* The patient is pregnant, parturient, or breastfeeding
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xavier Bobbia, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

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CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, , France

Site Status

Countries

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France

Other Identifiers

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2013-A00100-45

Identifier Type: OTHER

Identifier Source: secondary_id

LOCAL/2012/XB-01

Identifier Type: -

Identifier Source: org_study_id

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