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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04029051
Other study ID # 2015-036
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2016
Est. completion date June 1, 2019

Study information

Verified date July 2019
Source Nantes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 84
Est. completion date June 1, 2019
Est. primary completion date June 1, 2019
Accepts healthy volunteers No
Gender All
Age group 75 Years and older
Eligibility Inclusion Criteria:

- Acute onset dyspnea in patient over 74 years old consulting at the emergency department

Exclusion Criteria:

- Need for ICU

- Need for a mechanical ventilation

- Less than 24 hours hospital stay

- Inability to consent

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Focus thoracic ultrasound for dyspnea diagnosis
Focus thoracic ultrasound is composed by an advanced cardiac ultrasound with Doppler measures and a lung ultrasound.

Locations

Country Name City State
France Nantes University Hospital Nantes

Sponsors (1)

Lead Sponsor Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary main objective Concordance between initial diagnosis after standard care, after thoracic ultrasound in comparison with the reference stated by the adjudication committee 3 years
Secondary Frequency Frequency of each diagnosis in elderly patients consulting in the emergency department 3 years
Secondary mortality Assessing hospital mortality in elderly patients consulting at the emergency department 3 years
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