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CompletedNCT04223297Blue PUpdated Jan 18, 2023

Blue Protocol Assessment

An observational study in Dyspnea and Emergencies, sponsored by Centre Hospitalier Universitaire, Amiens. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-18.

Sponsored by Centre Hospitalier Universitaire, Amiens · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
115
Ages
18 Years and older
Sex
All
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Study 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

02

Conditions studied

  • Dyspnea
  • Emergencies

Keywords

  • dyspnea
  • lung ultrasound
  • emergency medicine
  • blue protocol
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In context

Dyspnea

655 studies on the registry are indexed under Dyspnea; 153 are open to participants now.

This study's enrollment of 115 is close to the median of 122 across 204 observational studies indexed under Dyspnea.

Browse Dyspnea studies →

Lead sponsor

Centre Hospitalier Universitaire, Amiens is the lead sponsor of 576 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • patient under a legal protection measure
  • lack of social security
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
115 participants (actual)
Patient registry
No

Interventions

  • Procedurelung ultrasound

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

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What researchers measure

Primary outcomes

  1. concordance between the clinical diagnosis and the final diagnosis

    comparison of the concordance between the clinical diagnosis and the final diagnosis

    Time frame: day of arrival in emergency

  2. concordance between the diagnosis establishes after the ultrasonography and the final diagnosis

    concordance between the diagnosis establishes after the ultrasonography and the final diagnosis

    Time frame: day of arrival in emergency

Secondary outcomes

  1. 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

    Time frame: 8 months

07

Study locations

1 site
  • CHU Amiens
    Amiens, 80054, France
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04223297
Lead sponsor
Centre Hospitalier Universitaire, Amiens
Collaborators
Centre Hospitalier de Clermont, Centre Hospitalier de Montreuil sur Mer, Centre Hospitalier de Beauvais, Centre Hospitalier de Compiègne, Centre Hospitalier de Doullens, Centre Hospitalier de Abbeville
Responsible party
Sponsor
First posted
Jan 10, 2020
Start date
Jan 1, 2020
Primary completion
Sep 1, 2020
Completion
Sep 1, 2020
Last update
Jan 18, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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