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

Primary Purpose

Dyspnea

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Standard care
Vscan portable ultrasound device (GE Healthcare, Wauwatosa, WI)
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dyspnea focused on measuring Vscan, portable ultrasound, emergency care, emergency room

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Nîmes - Hôpital Universitaire Carémeau

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard care

Standard care + ultrasound

Arm Description

Patients randomized to this arm will receive standard care. Intervention: Standard care.

Patients randomized to this arm will receive standard care + pleuropulmonary ultrasound. Intervention: Standard care + ultrasound

Outcomes

Primary Outcome Measures

Length of hospital stay in days

Secondary Outcome Measures

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

Full Information

First Posted
March 23, 2013
Last Updated
April 5, 2016
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT01818882
Brief Title
Diagnostic Value of Portable Ultrasound for Dyspneic Patient Support in the Emergency Department
Acronym
VSCAN-DYSP
Official Title
Evaluation of the Diagnostic Value of Portable Ultrasound for Dyspneic Patient Support in the Emergency Department: a Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Terminated
Why Stopped
Inclusion curve too slow.
Study Start Date
April 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspnea
Keywords
Vscan, portable ultrasound, emergency care, emergency room

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard care
Arm Type
Active Comparator
Arm Description
Patients randomized to this arm will receive standard care. Intervention: Standard care.
Arm Title
Standard care + ultrasound
Arm Type
Experimental
Arm Description
Patients randomized to this arm will receive standard care + pleuropulmonary ultrasound. Intervention: Standard care + ultrasound
Intervention Type
Other
Intervention Name(s)
Standard care
Intervention Description
Standard care for dyspneic patients including contextual analysis, conventional clinical exam and a chest X-Ray.
Intervention Type
Device
Intervention Name(s)
Vscan portable ultrasound device (GE Healthcare, Wauwatosa, WI)
Intervention Description
Standard care (as described for the other intervention) + pleuropulmonary ultrasound using the Vscan portable ultrasound device (GE Healthcare, Wauwatosa, WI).
Primary Outcome Measure Information:
Title
Length of hospital stay in days
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Patient deceased? yes/no
Time Frame
1 month
Title
Diagnosis in the emergency room
Time Frame
upon discharge from the emergency department (max 1 month)
Title
Diagnosis given by expert committee based on patient file
Time Frame
1 month
Title
Glasgow scale
Time Frame
Baseline, day 0
Title
Glasgow scale
Time Frame
day 3
Title
Heart rate
Time Frame
baseline, day 0
Title
Heart rate
Time Frame
day 3
Title
Respiratory rate
Time Frame
baseline, day 0
Title
Respiratory rate
Time Frame
day 3
Title
Systolic blood pressure
Time Frame
baseline, day 0
Title
Systolic blood pressure
Time Frame
day 3
Title
Diastolic blood pressure
Time Frame
baseline, day 0
Title
Diastolic blood pressure
Time Frame
day 3
Title
Temperature
Time Frame
baseline, day 0
Title
Temperature
Time Frame
day 3
Title
blood pH
Time Frame
baseline, day 0
Title
blood pH
Time Frame
day 3
Title
CO2 arterial pressure
Time Frame
baseline, day 0
Title
CO2 arterial pressure
Time Frame
day 3
Title
O2 arterial pressure
Time Frame
baseline, day 0
Title
O2 arterial pressure
Time Frame
day 3
Title
O2 saturation
Time Frame
baseline, day 0
Title
O2 saturation
Time Frame
day 3
Title
Alkaline reserve
Time Frame
baseline, day 0
Title
Alkaline reserve
Time Frame
day 3
Title
white blood cell count
Time Frame
baseline, day 0
Title
white blood cell count
Time Frame
day 3
Title
C-reactive protein
Time Frame
baseline, day 0
Title
C-reactive protein
Time Frame
day 3
Title
Brain Natriuretic Peptide
Time Frame
baseline, day 0
Title
Brain Natriuretic Peptide
Time Frame
day 3
Title
hemoglobin
Time Frame
baseline, day 0
Title
hemoglobin
Time Frame
day 3
Title
Pulmonary x-ray, yes/no
Time Frame
baseline, day 0
Title
right alveolar opacities on x-ray, yes/no
Time Frame
baseline, day 0
Title
left alveolar opacities on x-ray, yes/no
Time Frame
baseline, day 0
Title
right parenchymal origin on x-ray, yes/no
Time Frame
baseline, day 0
Title
left parenchymal origin on x-ray, yes/no
Time Frame
baseline, day 0
Title
right pleural effusion on x-ray, yes/no
Time Frame
baseline, day 0
Title
left pleural effusion on x-ray, yes/no
Time Frame
baseline, day 0
Title
pleuropulmonary ultrasound, yes/no
Time Frame
baseline, day 0
Title
right alveolar-interstitial syndrome on ultrasound, yes/no
Time Frame
baseline, day 0
Title
left alveolar-interstitial syndrome on ultrasound, yes/no
Time Frame
baseline, day 0
Title
right lung consolidation on ultrasound, yes/no
Time Frame
baseline, day 0
Title
left lung consolidation on ultrasound, yes/no
Time Frame
baseline, day 0
Title
right pleural effusion on ultrasound, yes/no
Time Frame
baseline, day 0
Title
left pleural effusion on ultrasound, yes/no
Time Frame
baseline, day 0
Title
right pneumothorax on ultrasound, yes/no
Time Frame
baseline, day 0
Title
left pneumothorax on ultrasound, yes/no
Time Frame
baseline, day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier Bobbia, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nîmes - Hôpital Universitaire Carémeau
City
Nîmes Cedex 9
ZIP/Postal Code
30029
Country
France

12. IPD Sharing Statement

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

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