DyspneaBlue PNCT04223297
Blue Protocol Assessment
An observational study of Dyspnea and Emergencies, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspnea, Emergencies
- What is being tested?
- lung ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 115 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2020to 1 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Each dyspneic patient meeting the inclusion criteria and admitted in emergency room will be included in the protocol.
Who may be able to join
- age over 18 years
- dyspneic patient requiring management by an emergency physician
- information given and no patient opposition.
Who cannot join
- patient under a legal protection measure
- lack of social security
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Dyspnea, Emergencies
- Being tested
- lung ultrasound
- Keywords
- dyspnea, lung ultrasound, emergency medicine, blue protocol
- Medical subject headings
- Dyspnea, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lung ultrasoundProcedure or surgery
The lung ultrasound will be performed by following the " Blue protocol "
What is being measured
The primary outcome is the main question the study is designed to answer.
concordance between the clinical diagnosis and the final diagnosis
comparison of the concordance between the clinical diagnosis and the final diagnosis
Measured: 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
Measured: 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
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start1 Jan 2020
- Primary completion1 Sep 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspneaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier de Clermont, Centre Hospitalier de Montreuil sur Mer, Centre Hospitalier de Beauvais, Centre Hospitalier Intercommunal de Compiègne-Noyon, Centre Hospitalier de Doullens, Centre Hospitalier de Abbeville
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04223297
- Sponsor's protocol ID
- PI2019_843_0046
- Acronym
- Blue P
- Status last verified
- Jan 2023
- First submitted
- 7 Jan 2020
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest Assessment of the Blue Protocol in Improving Diagnosis of Dyspneic Patients in Pre- and Intra-hospital Emergency Medicine
- ClinicalTrials.gov ID
- NCT04223297
- Acronym / sponsor ID
- Blue P / PI2019_843_0046
- Conditions
- Dyspnea, Emergencies
- Keywords
- dyspnea, lung ultrasound, emergency medicine, blue protocol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- Centre Hospitalier de Clermont, Centre Hospitalier de Montreuil sur Mer, Centre Hospitalier de Beauvais, Centre Hospitalier Intercommunal de Compiègne-Noyon, Centre Hospitalier de Doullens, Centre Hospitalier de Abbeville
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 10 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Each dyspneic patient meeting the inclusion criteria and admitted in emergency room will be included in the protocol.
Key inclusion criteria (3 listed)
- age over 18 years
- dyspneic patient requiring management by an emergency physician
- information given and no patient opposition.
Key exclusion criteria (2 listed)
- patient under a legal protection measure
- lack of social security
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lung ultrasoundThe lung ultrasound will be performed by following the " Blue protocol " | Procedure or surgery | – |
Primary outcome
concordance between the clinical diagnosis and the final diagnosis
Time frame: day of arrival in emergency
comparison of the concordance between the clinical diagnosis and the final diagnosis
concordance between the diagnosis establishes after the ultrasonography and the final diagnosis
Time frame: day of arrival in emergency
concordance between the diagnosis establishes after the ultrasonography and the final diagnosis
1 secondary outcome
Change of proportion of examinations leading to a change in the therapeutic hypothesis
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyspnea and Emergencies, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
concordance between the clinical diagnosis and the final diagnosis (time frame: day of arrival in emergency). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2023.