LUng and Cardiac Ultrasound for REspiratory Distress in ElDerly

Not Applicable

Not yet recruiting

• Conditions: Dyspnea; Respiratory Distress Syndrome

• Registration Number: NCT06807983
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

Prospective trial to evaluate the impact on the initial therapeutic inadequacy of a management strategy for acute dyspnea in the elderly based on the use of lung and cardiac ultrasonography.

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 Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-22
• Study First Submitted QC: 2025-01-28
• Last Update Submitted: 2025-01-28
• Study First Posted: 2025-02-04
• Last Update Posted: 2025-02-04
• Study Start: 2025-04-01
• Primary Completion: 2027-05-01
• Study Completion: 2027-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 504

Inclusion Criteria

• Patient over 65 years of age
• admitted to Emergency Department for acute dyspnea as chief complaint (defined as: sensation of shortness of breath progressing for less than 2 weeks) with objective signs of respiratory distress (Polypnea ≥ 22 breaths/min and SpO2 ≤ 92% on room air)
• consent to participate in the study or, failing that, a close relative or trusted support person, with the possibility of inclusion via the emergency procedure and the collection of informed consent a posteriori

Exclusion Criteria

• patient identified at end of life
• patient already included

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
therapeutic inadequacy	Hour 1	therapeutic inadequacy between initiated emergency treatments and the final diagnosis made by expert opinion

Secondary Outcome Measures

Name	Time	Method
correct diagnosis	emergency department discharge (up to hour 4)	correct diagnosis at the emergency department discharge (compared with final diagnosis made by expert opinion)
duration of emergency department stay	emergency department discharge (up to hour 4)	duration in emergency department (in hours)
Post-emergency hospital stay	Day 30	duration in Post-emergency hospital department: in medicine/surgery/obstetrics or follow-up and rehabilitation care (in days)
Number of days alive outside hospital between D0 and D30	Day 30	Number of days alive outside hospital between D0 and D30