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

This study is currently recruiting participants.
Verified April 2014 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01818882
First received: March 23, 2013
Last updated: April 4, 2014
Last verified: April 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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

Estimated Enrollment: 150
Study Start Date: April 2014
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01818882

Contacts
Contact: Xavier Bobbia, MD +33.(0)4.66.68.42.24 xavier.bobbia@chu-nimes.fr
Contact: Carey M Suehs, PhD +33.(0)4.66.68.67.88 carey.suehs@chu-nimes.fr

Locations
France
CHU de Nîmes - Hôpital Universitaire Carémeau Recruiting
Nîmes Cedex 9, France, 30029
Principal Investigator: Xavier Bobbia, MD         
Sub-Investigator: Rémi Perrin-Bayard, MD         
Sub-Investigator: Jean-Emmanuel de la Coussaye, MD, PhD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Xavier Bobbia, MD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

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
Study First Received: March 23, 2013
Last Updated: April 4, 2014
Health Authority: France: Committee for the Protection of Personnes
France: Agence Nationale de Sécurité du Médicament et des produits de santé

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

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

ClinicalTrials.gov processed this record on April 17, 2014