Non-invasive Evaluation of Cardiopulmonary Diseases Using Transthoracic Parametric Doppler Based Assessment of Lung Doppler Signals
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Echosense Ltd.
- Enrollment
- 600
- Locations
- 2
- Primary Endpoint
- Number of patients identified with COPD (or CHF) in comparison to physician diagnosis
Study Overview
Brief Summary
Historically, ultrasound imaging of the lung parenchyma has been challenging because of the high total ultrasound energy attenuation and scattering by the air in the lungs. However, recent technological advancements have allowed for rapid assessment of various pulmonary diseases via the use of lung ultrasound. Furthermore, it has been shown that clear reproducible Doppler signals can be recorded from the lung parenchyma by means of a pulsed Doppler ultrasound system incorporating a special signal-processing package.
The LDS may contain information of significant diagnostic and physiological value regarding the pulmonary parenchyma and vasculature, as well as the cardio-vascular system in general. In a pilot clinical validation study of patients with acute decompensated heart failure (ADHF) patients, LDS signals unique to ADHF patients were identified, that superpose on the normal Lung Doppler Signals (unpublished data). These are high velocity "disorganized" variable signals that are not synchronous with the cardiac cycle but rather sometimes with respiration.
Detailed Description
Study Purpose and Rationale
The purpose of this study is to assess the utility of noninvasive assessment of lung Doppler signals performed via transthoracic parametric Doppler. The study has two major objectives and is thus, divided into two phases, which are on a continuum.
Phase 1: The objective is to further evaluate LDS among patients presenting to the emergency department with acute dyspnea, in order to determine the diagnostic value of this non-invasive method to distinguish cardiac from pulmonary causes of dyspnea.
Phase 2: In addition, for those patients admitted to the hospital with a clinical diagnosis of ADHF, we would like to further characterize changes in daily lung Doppler signal as a surrogate biomarker of intravascular volume status, as assessed by clinical assessment.
Study Design and Methods:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Phase 1(ED):
- •Inclusion criteria:
- •Age > 18 years Acute onset dyspnea
- •Phase 2 (Inpatient):
- •Age > 18 years Acute onset dyspnea: defined as SOB at rest or with minimal activity, with onset within the past 14 days PLUS
- •The following criteria are required to be classified as heart failure (event has to meet all of the following criteria):
- •a) The patient exhibits documented new or worsening symptoms due to heart failure on presentation, including at least one of the following: i) Dyspnea (dyspnea with exertion, dyspnea at rest, orthopnea) ii) Decreased exercise tolerance b) The patient has objective evidence of new or worsening heart failure, consisting of at least two physical exam findings (or one physical exam finding and one diagnostic criterion) including: i) Physical exam findings considered to be due to heart failure, including new or worsened:
- •(1) Peripheral edema (2) Increasing abdominal distention or ascites (in the absence of primary hepatic disease) (3) Increased jugular venous pressure and/or hepatojugular reflux (4) Rapid weight gain thought to be related to fluid overload ii) Diagnostic findings considered to be due to heart failure, including new or worsened:
- •Increased B-type natriuretic peptide/ NT-proBNP concentrations consistent with decompensation of heart failure Note: In patients with chronically elevated natriuretic peptides, a significant increase should be noted above baseline.
- •Radiological evidence of pulmonary congestion
Exclusion Criteria
- •Phase 1 (ED):
- •Pregnant women Inability to consent
- •Phase 2 (Inpatient):
- •Pregnant women Pneumonia - currently, or within the past 30 days Non-cardiogenic pulmonary edema (e.g. ARDS) Interstitial lung disease Inability to consent
Outcomes
Primary Outcomes
Number of patients identified with COPD (or CHF) in comparison to physician diagnosis
Time Frame: 1y
Secondary Outcomes
- Identify changes in lung doppler signals according to the clinical status over few days in comparison to the physician diagnosis(1y)