NCT04223297

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 10, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

January 18, 2023

Status Verified

January 1, 2023

Enrollment Period

8 months

First QC Date

January 7, 2020

Last Update Submit

January 17, 2023

Conditions

Keywords

dyspnealung ultrasoundemergency medicineblue protocol

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Change of proportion of examinations leading to a change in the therapeutic hypothesis

    8 months

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • age over 18 years
  • dyspneic patient requiring management by an emergency physician
  • information given and no patient opposition.

You may not qualify if:

  • patient under a legal protection measure
  • lack of social security

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80054, France

Location

MeSH Terms

Conditions

DyspneaEmergencies

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2020

First Posted

January 10, 2020

Study Start

January 1, 2020

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

January 18, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations