跳至主要内容
临床试验/NCT06807983
NCT06807983招募中不适用

Impact of a Management Strategy for Acute Dyspnea in Elderly Subjects Based on the Use of Lung and Cardiac Ultrasonography

University Hospital, Toulouse1 个研究点 分布在 1 个国家目标入组 504 人开始时间: 2025年11月4日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
504
试验地点
1
主要终点
therapeutic inadequacy

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

盲法说明

Diagnostic classification and therapeutic adequacy or inadequacy will be established by expert appraisal of the files by 2 experts (a cardiologist and a pulmonologist ) blind to the results of the clinical ultrasound and the the other expert.

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

therapeutic inadequacy

时间窗: Hour 1

therapeutic inadequacy between initiated emergency treatments and the final diagnosis made by expert opinion

次要结局

  • correct diagnosis(emergency department discharge (up to hour 4))
  • duration of emergency department stay(emergency department discharge (up to hour 4))
  • Post-emergency hospital stay(Day 30)
  • Number of days alive outside hospital between D0 and D30(Day 30)
  • Care cost(Day 30)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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