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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of the Diagnostic Value of Portable Ultrasound for Dyspneic Patient Support in the Emergency Department: a Randomized Study

Conditions
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Dyspnea

Intervention / Treatment
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* Other: Standard care
* Device: Vscan portable ultrasound device (GE Healthcare, Wauwatosa, WI)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard care<br>Patients randomized to this arm will receive standard care. Intervention: Standard care. | Other: Standard care<br>* Standard care for dyspneic patients including contextual analysis, conventional clinical exam and a chest X-Ray.<br>|
| Experimental: Standard care + ultrasound<br>Patients randomized to this arm will receive standard care + pleuropulmonary ultrasound. Intervention: Standard care + ultrasound | Other: Standard care<br>* Standard care for dyspneic patients including contextual analysis, conventional clinical exam and a chest X-Ray.<br>Device: Vscan portable ultrasound device (GE Healthcare, Wauwatosa, WI)<br>* Standard care (as described for the other intervention) + pleuropulmonary ultrasound using the Vscan portable ultrasound device (GE Healthcare, Wauwatosa, WI).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay in days |  | 1 month | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vscan, portable ultrasound, emergency care, emergency room