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

Not Applicable

Terminated

• Conditions: Dyspnea
• Interventions: Other: Standard care; Device: Vscan portable ultrasound device (GE Healthcare, Wauwatosa, WI)

• Registration Number: NCT01818882
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2013-03-23
• Study First Submitted QC: 2013-03-26
• Study First Posted: 2013-03-27
• Study Start: 2014-04
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-03
• Last Update Submitted: 2016-04-05
• Last Update Posted: 2016-04-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 85

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard care + ultrasound	Standard care	Patients randomized to this arm will receive standard care + pleuropulmonary ultrasound. Intervention: Standard care + ultrasound
Standard care + ultrasound	Vscan portable ultrasound device (GE Healthcare, Wauwatosa, WI)	Patients randomized to this arm will receive standard care + pleuropulmonary ultrasound. Intervention: Standard care + ultrasound
Standard care	Standard care	Patients randomized to this arm will receive standard care. Intervention: Standard care.

Primary Outcome Measures

Name	Time	Method
Length of hospital stay in days	1 month

Secondary Outcome Measures

Name	Time	Method
Patient deceased? yes/no	1 month
CO2 arterial pressure	day 3
Glasgow scale	day 3
Temperature	day 3
Alkaline reserve	day 3
hemoglobin	day 3
Pulmonary x-ray, yes/no	baseline, day 0
Diagnosis given by expert committee based on patient file	1 month
Heart rate	day 3
white blood cell count	day 3
C-reactive protein	day 3
right parenchymal origin on x-ray, yes/no	baseline, day 0
left pleural effusion on ultrasound, yes/no	baseline, day 0
right pneumothorax on ultrasound, yes/no	baseline, day 0
Diagnosis in the emergency room	upon discharge from the emergency department (max 1 month)
Respiratory rate	day 3
Systolic blood pressure	day 3
Diastolic blood pressure	day 3
blood pH	day 3
right alveolar opacities on x-ray, yes/no	baseline, day 0
left parenchymal origin on x-ray, yes/no	baseline, day 0
right pleural effusion on x-ray, yes/no	baseline, day 0
right alveolar-interstitial syndrome on ultrasound, yes/no	baseline, day 0
O2 arterial pressure	day 3
Brain Natriuretic Peptide	day 3
pleuropulmonary ultrasound, yes/no	baseline, day 0
left alveolar-interstitial syndrome on ultrasound, yes/no	baseline, day 0
right lung consolidation on ultrasound, yes/no	baseline, day 0
left lung consolidation on ultrasound, yes/no	baseline, day 0
left alveolar opacities on x-ray, yes/no	baseline, day 0
left pleural effusion on x-ray, yes/no	baseline, day 0
left pneumothorax on ultrasound, yes/no	baseline, day 0
O2 saturation	day 3
right pleural effusion on ultrasound, yes/no	baseline, day 0

Trial Locations

Locations (1)

CHU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 9, France