DyspneaechoelderlyNCT04029051
Focus Thoracic Ultrasound for Dyspnea Diagnosis in Elderly Patient in the Emergency Department
An observational study of Dyspnea, run by Nantes University Hospital at 1 site in France.
Trial summary
Brief Summary: The aim of this study is to analyze in elderly patients with undifferentiated dyspnea, the concordance of diagnosis before and after a focus thoracic ultrasound in comparison with the reference one established by an adjudication committee Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Dyspnea
- What is being tested?
- Focus thoracic ultrasound for dyspnea diagnosis
- How many people
- 84 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2016to 1 Jun 2019
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly patient consulting in the emergency department for acute onset dyspnea
Who may be able to join
- Acute onset dyspnea in patient over 74 years old consulting at the emergency department
Who cannot join
- Need for ICU
- Need for a mechanical ventilation
- Less than 24 hours hospital stay
- Inability to consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Focus Thoracic Ultrasound for Dyspnea Diagnosis in Elderly Patient in the ED: Prospective Observational Study
Brief Summary: The aim of this study is to analyze in elderly patients with undifferentiated dyspnea, the concordance of diagnosis before and after a focus thoracic ultrasound in comparison with the reference one established by an adjudication committee
Read the detailed description
Dyspnea is associated with a variety of etiology whose diagnosis is challenging especially in elderly patients with unconventional symptoms. Focus thoracic ultrasound is composed by an advanced cardiac ultrasound with Doppler measures and a lung ultrasound. It has already demonstrated its ability to reduce diagnosis uncertainty in emergency patients with dyspnea. However, adequacy of diagnosis before and after thoracic ultrasound has not been investigated in such patients.
In this population, after clinical examination and use of any resource deemed necessary, the physician states its hypothesis in closed list. An emergency physician then realizes a thoracic ultrasound exam. An adjudication committee with all the patient's file will state the reference hypothesis.
- Conditions
- Dyspnea
- Being tested
- Focus thoracic ultrasound for dyspnea diagnosis
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus thoracic ultrasound for dyspnea diagnosisOther
Focus thoracic ultrasound is composed by an advanced cardiac ultrasound with Doppler measures and a lung ultrasound.
What is being measured
The primary outcome is the main question the study is designed to answer.
main objective
Concordance between initial diagnosis after standard care, after thoracic ultrasound in comparison with the reference stated by the adjudication committee
Measured: 3 years
Secondary outcomes (2)
Frequency
Frequency of each diagnosis in elderly patients consulting in the emergency department
Measured: 3 years
mortality
Assessing hospital mortality in elderly patients consulting at the emergency department
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start1 Jan 2016
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyspneaStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04029051
- Sponsor's protocol ID
- 2015-036
- Acronym
- echoelderly
- Status last verified
- Jul 2019
- First submitted
- 19 Jul 2019
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
De Carvalho H, Javaudin F, Le Bastard Q, Boureau AS, Montassier E, Le Conte P. Effect of chest ultrasound on diagnostic workup in elderly patients with acute respiratory failure in the emergency department: a prospective study. Eur J Emerg Med. 2021 Jan 1;28(1):29-33. doi: 10.1097/MEJ.0000000000000732.
PubMed 32568788
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focus Thoracic Ultrasound for Dyspnea Diagnosis in Elderly Patient in the ED: Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04029051
- Acronym / sponsor ID
- echoelderly / 2015-036
- Conditions
- Dyspnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 23 Jul 2019 (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.
Brief Summary: The aim of this study is to analyze in elderly patients with undifferentiated dyspnea, the concordance of diagnosis before and after a focus thoracic ultrasound in comparison with the reference one established by an adjudication committee
Detailed description
Dyspnea is associated with a variety of etiology whose diagnosis is challenging especially in elderly patients with unconventional symptoms. Focus thoracic ultrasound is composed by an advanced cardiac ultrasound with Doppler measures and a lung ultrasound. It has already demonstrated its ability to reduce diagnosis uncertainty in emergency patients with dyspnea. However, adequacy of diagnosis before and after thoracic ultrasound has not been investigated in such patients.
In this population, after clinical examination and use of any resource deemed necessary, the physician states its hypothesis in closed list. An emergency physician then realizes a thoracic ultrasound exam. An adjudication committee with all the patient's file will state the reference hypothesis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly patient consulting in the emergency department for acute onset dyspnea
Key inclusion criteria (1 listed)
- Acute onset dyspnea in patient over 74 years old consulting at the emergency department
Key exclusion criteria (4 listed)
- Need for ICU
- Need for a mechanical ventilation
- Less than 24 hours hospital stay
- Inability to consent
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 |
|---|---|---|
| Focus thoracic ultrasound for dyspnea diagnosisFocus thoracic ultrasound is composed by an advanced cardiac ultrasound with Doppler measures and a lung ultrasound. | Other | – |
Primary outcome
main objective
Time frame: 3 years
Concordance between initial diagnosis after standard care, after thoracic ultrasound in comparison with the reference stated by the adjudication committee
2 secondary outcomes
Frequency
Time frame: 3 years
mortality
Time frame: 3 years
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 23 Jul 2019.
- Derived from this study: PubMed 32568788De Carvalho H, Javaudin F, Le Bastard Q, Boureau AS, Montassier E, Le Conte P. Effect of chest ultrasound on diagnostic workup in elderly patients with acute respiratory failure in the emergency department: a prospective study. Eur J Emerg Med. 2021 Jan 1;28(1):29-33. doi: 10.1097/MEJ.0000000000000732.
- 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, run by Nantes University Hospital 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 1 inclusion and 4 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 23 Jul 2019. 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?
main objective (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04029051, which also lists 1 linked publication.
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 23 Jul 2019.