Dyspnea Clinical Trial
Official title:
Non-invasive Evaluation of Cardiopulmonary Diseases Using Transthoracic Parametric Doppler Based Assessment of Lung Doppler Signals
NCT number | NCT02248831 |
Other study ID # | DOP19 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2014 |
Est. completion date | December 2018 |
Verified date | November 2016 |
Source | Echosense Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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normal Lung Doppler Signals (unpublished data).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.
Status | Completed |
Enrollment | 600 |
Est. completion date | December 2018 |
Est. primary completion date | May 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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: 1. 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. 2. 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 |
Country | Name | City | State |
---|---|---|---|
United States | Emergency Medicine department and Inpatients floors,MGH | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Echosense Ltd. | Massachusetts General Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients identified with COPD (or CHF) in comparison to physician diagnosis | 1y | ||
Secondary | Identify changes in lung doppler signals according to the clinical status over few days in comparison to the physician diagnosis | 1y |
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