LUng and Cardiac Ultrasound for REspiratory Distress in ElDerly (LUCREED)
Impact of a Management Strategy for Acute Dyspnea in Elderly Subjects Based on the Use of Lung and Cardiac Ultrasonography
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Acute dyspnea is a frequent and serious reason of admission in Emergency Department (ED), with a one-month mortality close to 16%. It is difficult to diagnose in the initial assessment phase since the cause of this symptom can vary (cardiological, pulmonary, infectious, etc.) and the symptoms can be misleading. This difficulty in diagnosing delays the implementation of appropriate therapeutic management even as the timeliness of management is associated with a reduction in mortality. These issues are particularly important in the elderly.
Lung and cardiac ultrasonography performed by the emergency physician, immediately available at the patient's bedside, could reduce the diagnostic and therefore therapeutic delay.
However, the impact of a diagnostic strategy based on lung and cardiac ultrasonography in dyspneic elderly subjects has not been evaluated.
Patients will be randomized in two groups : "standard of care" or "clinical ultrasound" group. Treatments initiated in Emergency Department (ED) will be noted to be compared to final diagnosis.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Manon Hebrard
- Phone Number: +33 561322271
- Email: hebrard.m@chu-toulouse.fr
Study Locations
-
-
-
Toulouse, France
- Recruiting
- UHToulouse
-
Principal Investigator:
- Frédéric BALEN, MD
-
Contact:
- Manon HEBRARD
- Email: hebrard.m@chu-toulouse.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Eligible patients will be aged over 65 years, affiliated with the French social security system, and presenting to the ED with acute dyspnea (onset <14 days) accompanied by severity signs before or at triage (respiratory rate ≥22 and SpO2 <92% on room air). The enrolling emergency physician (EP) must be the patient's treating physician and must be trained in LuCUS. Written informed consent from the patient or their legal representative is required for inclusion
Exclusion Criteria:
dyspnea secondary to thoracic trauma, dyspnea clearly related to COVID-19, known pulmonary fibrosis or lung cancer, prior administration of specific treatment for dyspnea before inclusion, immediate need for endotracheal intubation, patients identified as being at end-of-life, and individuals under legal guardianship or deprived of liberty.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: clinical ultrasound
diagnostic strategy based on the protocolized implementation of clinical lung and cardiac ultrasonography, with a proposed diagnostic and therapeutic focus based on the results.
|
cardiopulmonary ultrasound performed by the emergency physician, immediately at patient's bed
|
|
No Intervention: standard care
diagnostic and therapeutic strategy based on the usual practices of the department and the clinician
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
therapeutic inadequacy
Time Frame: Hour 1
|
therapeutic inadequacy between initiated emergency treatments and the final diagnosis made by expert opinion
|
Hour 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
correct diagnosis
Time Frame: emergency department discharge (up to hour 4)
|
correct diagnosis at the emergency department discharge (compared with final diagnosis made by expert opinion)
|
emergency department discharge (up to hour 4)
|
|
duration of emergency department stay
Time Frame: emergency department discharge (up to hour 4)
|
duration in emergency department (in hours)
|
emergency department discharge (up to hour 4)
|
|
Post-emergency hospital stay
Time Frame: Day 30
|
duration in Post-emergency hospital department: in medicine/surgery/obstetrics or follow-up and rehabilitation care (in days)
|
Day 30
|
|
Number of days alive outside hospital between D0 and D30
Time Frame: Day 30
|
Number of days alive outside hospital between D0 and D30
|
Day 30
|
|
Care cost
Time Frame: Day 30
|
Care cost - Direct and indirect medical cost looking at French social security spendings for patients
|
Day 30
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Frédéric BALEN, MD, University Hospital, Toulouse
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC31/23/0386
- 2024-A01678-39 (Other Identifier: ID-RCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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