Blue Protocol Assessment

Dyspnea Clinical Trial

— Blue P  

Official title:

Interest Assessment of the Blue Protocol in Improving Diagnosis of Dyspneic Patients in Pre- and Intra-hospital Emergency Medicine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04223297
• Other study ID #: PI2019_843_0046
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: September 1, 2020

Study information

• Verified date: January 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Acute dyspnea is a common disease in emergency medicine. Mortality remains high is estimated at 15%. One third of initial diagnoses before paraclinical examination are estimated to be inaccurate. Lung ultrasound is a quick and immediate examination. Also, it is provided and performed at the bedside. The " Blue protocol " was designed by Daniel A. Lichtenstein as a diagnostic aid in dyspneic patients. It allows to obtain a diagnostic in more than 90% of acute dyspnea. However there is no validation in emergency medicine.

The main purpose is to evaluate the interest of the " Blue protocol "in the management and orientation of the dyspneic patient

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: September 1, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age over 18 years

• dyspneic patient requiring management by an emergency physician

• information given and no patient opposition.

Exclusion Criteria:

• patient under a legal protection measure

• lack of social security

Related Conditions & MeSH terms

• Dyspnea
• Emergencies

Intervention

Procedure:
• lung ultrasound
The lung ultrasound will be performed by following the " Blue protocol "

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (7)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens	Centre Hospitalier de Abbeville, Centre Hospitalier de Beauvais, Centre Hospitalier de Clermont, Centre Hospitalier de Compiègne, Centre Hospitalier de Doullens, Centre Hospitalier de Montreuil sur Mer

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	concordance between the clinical diagnosis and the final diagnosis	comparison of the concordance between the clinical diagnosis and the final diagnosis	day of arrival in emergency
Primary	concordance between the diagnosis establishes after the ultrasonography and the final diagnosis	concordance between the diagnosis establishes after the ultrasonography and the final diagnosis	day of arrival in emergency
Secondary	Change of proportion of examinations leading to a change in the therapeutic hypothesis	Change of proportion of examinations leading to a change in the therapeutic hypothesis	8 months