Clinical trial NCT01818882: Diagnostic Value of Portable Ultrasound for Dyspneic Patient Support in the Emergency Department
Official title: Evaluation of the Diagnostic Value of Portable Ultrasound for Dyspneic Patient Support in the Emergency Department: a Randomized Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Dyspnea
Keywords: Vscan
portable ultrasound
emergency care
emergency room
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2013-03-27
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Length of hospital stay in days
timeFrame: 1 month
Secondary outcomes:
measure: Patient deceased? yes/no
timeFrame: 1 month
measure: Diagnosis in the emergency room
timeFrame: upon discharge from the emergency department (max 1 month)
measure: Diagnosis given by expert committee based on patient file
timeFrame: 1 month
measure: Glasgow scale
timeFrame: Baseline, day 0
measure: Glasgow scale
timeFrame: day 3
measure: Heart rate
timeFrame: baseline, day 0
measure: Heart rate
timeFrame: day 3
measure: Respiratory rate
timeFrame: baseline, day 0
measure: Respiratory rate
timeFrame: day 3
measure: Systolic blood pressure
timeFrame: baseline, day 0
measure: Systolic blood pressure
timeFrame: day 3
measure: Diastolic blood pressure
timeFrame: baseline, day 0
measure: Diastolic blood pressure
timeFrame: day 3
measure: Temperature
timeFrame: baseline, day 0
measure: Temperature
timeFrame: day 3
measure: blood pH
timeFrame: baseline, day 0
measure: blood pH
timeFrame: day 3
measure: CO2 arterial pressure
timeFrame: baseline, day 0
measure: CO2 arterial pressure
timeFrame: day 3
measure: O2 arterial pressure
timeFrame: baseline, day 0
measure: O2 arterial pressure
timeFrame: day 3
measure: O2 saturation
timeFrame: baseline, day 0
measure: O2 saturation
timeFrame: day 3
measure: Alkaline reserve
timeFrame: baseline, day 0
measure: Alkaline reserve
timeFrame: day 3
measure: white blood cell count
timeFrame: baseline, day 0
measure: white blood cell count
timeFrame: day 3
measure: C-reactive protein
timeFrame: baseline, day 0
measure: C-reactive protein
timeFrame: day 3
measure: Brain Natriuretic Peptide
timeFrame: baseline, day 0
measure: Brain Natriuretic Peptide
timeFrame: day 3
measure: hemoglobin
timeFrame: baseline, day 0
measure: hemoglobin
timeFrame: day 3
measure: Pulmonary x-ray, yes/no
timeFrame: baseline, day 0
measure: right alveolar opacities on x-ray, yes/no
timeFrame: baseline, day 0
measure: left alveolar opacities on x-ray, yes/no
timeFrame: baseline, day 0
measure: right parenchymal origin on x-ray, yes/no
timeFrame: baseline, day 0
measure: left parenchymal origin on x-ray, yes/no
timeFrame: baseline, day 0
measure: right pleural effusion on x-ray, yes/no
timeFrame: baseline, day 0
measure: left pleural effusion on x-ray, yes/no
timeFrame: baseline, day 0
measure: pleuropulmonary ultrasound, yes/no
timeFrame: baseline, day 0
measure: right alveolar-interstitial syndrome on ultrasound, yes/no
timeFrame: baseline, day 0
measure: left alveolar-interstitial syndrome on ultrasound, yes/no
timeFrame: baseline, day 0
measure: right lung consolidation on ultrasound, yes/no
timeFrame: baseline, day 0
measure: left lung consolidation on ultrasound, yes/no
timeFrame: baseline, day 0
measure: right pleural effusion on ultrasound, yes/no
timeFrame: baseline, day 0
measure: left pleural effusion on ultrasound, yes/no
timeFrame: baseline, day 0
measure: right pneumothorax on ultrasound, yes/no
timeFrame: baseline, day 0
measure: left pneumothorax on ultrasound, yes/no
timeFrame: baseline, day 0
Other outcomes:
Locations:
city: Nîmes Cedex 9
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Xavier Bobbia, MD
role: PRINCIPAL_INVESTIGATOR
References: