NCT03998410

Evaluation of the Diagnostic Value of the TPD System in Determining ADHF Causing Acute Dyspnea

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Echosense Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate Lung Doppler signals (LDS) among patients presenting to the emergency department with acute dyspnea, in order to determine the diagnostic value of this non-invasive method to discriminate ADHF causing dyspnea from any other cause i.e., non-ADHF causes of dyspnea.

Detailed description

Dyspnea (shortness of breath) is a common symptom affecting as many as 25% of patients seen in ambulatory settings. It can be caused by many different underlying conditions, some of which arise acutely and can be life-threatening, making rapid clinical evaluation and targeted diagnostic studies of central importance. A number of disorders cause dyspnea, including acute decompensated heart failure (ADHF), chronic obstructive pulmonary disease (COPD), asthma, pulmonary embolism, pneumonia, metabolic acidosis, neuromuscular weakness, and others. The overlapping clinical presentations of these conditions and comorbid diseases can make the diagnostic evaluation of dyspnea a significant challenge. Acute heart failure (AHF) is a major cause of serious morbidity and death in the general population and one of the most common medical causes of hospitalization among people aged over 60. Patients presenting to the ED with ADHF must be evaluated and treated rapidly to ensure the best possible outcomes. The diagnosis should be made as soon as possible and therapy initiated. Delayed diagnosis at presentation may also result in patients being inappropriately transferred to non-specialist wards, resulting in longer stays, increased re-admission and poorer outcomes. The key to improving the time to diagnosis depends on the clinical evaluation alongside a readiness to initiate relevant additional tests. Previous studies showed that the TPD has the potential to differentiate between the cardiac cause of dyspnea and any other cause.

Conditions

• ADHF

Interventions

Type	Name	Description
DEVICE	Lung Doppler Signals	Recording Doppler ultrasound on the right chest wall

Timeline

• Start date: 2019-09-15
• Primary completion: 2021-07-01
• Completion: 2021-07-01
• First posted: 2019-06-26
• Last updated: 2024-09-19

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study