Evaluation of Lung Doppler Signals in Patients Presenting to EMD

NCT01961141 | Withdrawn

• 1 other identifier: DOP17
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Historically, ultrasound has been unable to provide interpretable data from the lung parenchyma, mainly because of the high total ultrasound energy attenuation and scattering by the air in the lungs. Recently 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 (transthoracic parametric Doppler, TPD, EchoSense Ltd., Haifa, Israel). These lung Doppler signals (LDS) are in full synchrony with the cardiac cycle and can be obtained from the lungs, including areas remote from the heart and main pulmonary vessels. The LDS waves typically have peak velocities of up to 30 cm/s and are of relatively high power, making it possible to detect them despite the aforementioned attenuation by the air in the lungs. The LDS are thought to represent the radial wall movement of small pulmonary blood vessels, caused by pressure pulse waves of cardiac origin which propagate throughout the lung vasculature. 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. Preliminary data from ongoing studies employing the TPD in chronic diseases such as CHF, COPD and pulmonary hypertension, show promise regarding the diagnostic potential of the lung Doppler signals (unpublished data). However, lung Doppler signals in acute disease states were not investigated so far. It is reasonable to speculate that the pathological processes underlying acute cardiovascular and pulmonary diseases will affect the LDS. Therefore, the TPD may have diagnostic potential in these conditions. For example, during acute pulmonary embolism a portion of the pulmonary vascular system is occluded; therefore it's reasonable to assume that the LDS will disappear in the affected area, enabling to confirm the diagnosis without using ionizing radiation (as in CT or lung scan). Another example is COPD exacerbation, during which there is usually air trapping in the lungs; thus, the LDS may be attenuated by the increase of air volume in the lungs.

Conditions

Acute Cardiovascular; Pneumonia; Pulmonary Embolism; CHF Exacerbation; COPD Exacerbation

Keywords

Ultrasound Doppler; Pulmonary diseases; Cardiopulmonary conditions

Outcome Measures

Primary Outcomes (1)

• Diagnose irregular pattern of lung Doppler signals recorded in patients by features as velocity, power ect in comparison to control pattern

  1.5y to collect all data required to obtain a diagnostic pattern

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to the EMD with acute cardiovascular and/or pulmonary conditions, including- but not restricted to- pneumonia, pulmonary embolism, CHF exacerbation, COPD exacerbation, shock, etc.

You may qualify if:

• Men or women aged over 18. Suspected or confirmed acute cardiovascular or pulmonary condition.

You may not qualify if:

• Minor (aged \< 18). People unwilling to give informed consent. Pregnant women.

Sponsors & Collaborators

• Echosense Ltd.: lead

Study Sites (1)

Rambam Medical center

Haifa, Israel

Location

MeSH Terms

Conditions

Pneumonia; Pulmonary Embolism; Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Shlomo Israelit, MD

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2013
• First Posted: October 11, 2013
• Study Start: November 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: June 1, 2015
• Last Updated: August 13, 2015

Record last verified: 2013-05

Locations

IL (1)