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

This study has been terminated.
(Inclusion curve too slow.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01818882
First Posted: March 27, 2013
Last Update Posted: April 6, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
  Purpose
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.

Condition Intervention
Dyspnea Other: Standard care Device: Vscan portable ultrasound device (GE Healthcare, Wauwatosa, WI)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of the Diagnostic Value of Portable Ultrasound for Dyspneic Patient Support in the Emergency Department: a Randomized Study

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • Length of hospital stay in days [ Time Frame: 1 month ]

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

Enrollment: 85
Study Start Date: April 2014
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01818882


Locations
France
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 9, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Xavier Bobbia, MD Centre Hospitalier Universitaire de Nîmes
  More Information

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01818882     History of Changes
Other Study ID Numbers: LOCAL/2012/XB-01
2013-A00100-45 ( Other Identifier: RCB number )
First Submitted: March 23, 2013
First Posted: March 27, 2013
Last Update Posted: April 6, 2016
Last Verified: March 2016

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
Vscan
portable ultrasound
emergency care
emergency room

Additional relevant MeSH terms:
Emergencies
Dyspnea
Disease Attributes
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms