Diagnostic Value of Portable Ultrasound for Dyspneic Patient Support in the Emergency Department (VSCAN-DYSP)

Evaluation of the Diagnostic Value of Portable Ultrasound for Dyspneic Patient Support in the Emergency Department: a Randomized Study

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.

Study Overview

• Status: Terminated
• Conditions: Dyspnea
• Intervention / Treatment: Other: Standard care; Device: Vscan portable ultrasound device (GE Healthcare, Wauwatosa, WI)

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 Type: Interventional
• Enrollment (Actual): 85
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nîmes Cedex 9, France, 30029
    • CHU de Nîmes - Hôpital Universitaire Carémeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard care; Patients randomized to this arm will receive standard care. Intervention: Standard care.	Other: Standard care; Standard care for dyspneic patients including contextual analysis, conventional clinical exam and a chest X-Ray.
Experimental: Standard care + ultrasound; Patients randomized to this arm will receive standard care + pleuropulmonary ultrasound. Intervention: Standard care + ultrasound	Other: Standard care; Standard care for dyspneic patients including contextual analysis, conventional clinical exam and a chest X-Ray.; Device: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Length of hospital stay in days	1 month

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: March 23, 2013
• First Submitted That Met QC Criteria: March 26, 2013
• First Posted (Estimate): March 27, 2013

Study Record Updates

• Last Update Posted (Estimate): April 6, 2016
• Last Update Submitted That Met QC Criteria: April 5, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: portable ultrasound; emergency room; Vscan; emergency care
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Disease Attributes; Signs and Symptoms, Respiratory; Emergencies; Dyspnea
• Other Study ID Numbers: LOCAL/2012/XB-01; 2013-A00100-45 (Other Identifier: RCB number)