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

Dyspnea Clinical Trial

— VSCAN-DYSP  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01818882
• Other study ID #: LOCAL/2012/XB-01
• Secondary ID: 2013-A00100-45
• Status: Terminated
• Phase: N/A
• First received: March 23, 2013
• Last updated: April 5, 2016
• Start date: April 2014
• Est. completion date: January 2016

Study information

• Verified date: March 2016
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 85
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dyspnea
• Emergencies

Intervention

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).

Locations

Country	Name	City	State
France	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 9

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

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