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

This study is currently recruiting participants. (see Contacts and Locations)
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
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, see Learn About Clinical Studies.

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:
Emergencies
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on September 29, 2014