Blue Protocol Assessment (Blue P)

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

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

Study Overview

• Status: Completed
• Conditions: Emergencies; Dyspnea
• Intervention / Treatment: Procedure: lung ultrasound

• Study Type: Observational
• Enrollment (Actual): 115

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80054
    • CHU Amiens

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Each dyspneic patient meeting the inclusion criteria and admitted in emergency room will be included in the protocol.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Collaborators: Centre Hospitalier de Beauvais; Centre Hospitalier de Clermont; Centre Hospitalier de Montreuil sur Mer; centre hospitalier de Compiegne; Centre Hospitalier de Doullens; Centre Hospitalier de Abbeville

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): September 1, 2020
• Study Completion (Actual): September 1, 2020

Study Registration Dates

• First Submitted: January 7, 2020
• First Submitted That Met QC Criteria: January 7, 2020
• First Posted (Actual): January 10, 2020

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 17, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: lung ultrasound; dyspnea; emergency medicine; blue protocol
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Disease Attributes; Signs and Symptoms, Respiratory; Emergencies; Dyspnea
• Other Study ID Numbers: PI2019_843_0046

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No