Ignite Creation Date:
2024-05-06 @ 1:50 AM
Last Modification Date:
2024-10-26 @ 11:10 AM
Study NCT ID:
NCT01913457
Status:
TERMINATED
Last Update Posted:
2022-03-23
First Post:
2013-07-25
Brief Title:
Measurements and Characterization of Doppler Signals From the Right Chest in Pediatric and Adult Patients
Sponsor:
Echosense Ltd
Organization:
Echosense Ltd
Study Overview
Official Title:
Evaluation of Lung Doppler Signals in Pediatric and Adult Patients
Status:
TERMINATED
Status Verified Date:
2019-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 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 cms 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
Pulmonary arterial hypertension PAH is a condition characterized by reshaping of the small pulmonary arteries with increase in pulmonary vascular resistance leading gradually to right-sided cardiac failure A trans-thoracic echocardiograph TTE is a test classically undertaken in order to screen for pulmonary hypertension However the systolic pulmonary artery pressure SPAP values thereby obtained are often imprecise and depend upon the expertise of the individual carrying out the test Therefore the pulmonary arterial pressure and cardiac output values have to be ascertained with a right-sided cardiac catheterization which is considered the gold-standard but is invasive
In a pilot study of adult PAH patients unpublished lung Doppler signals have been shown to have the potential to diagnose pulmonary hypertension in two different ways First by measuring the degree of attenuation of the LDS during acute pressure rise in the chest cavity ie during Valsalva maneuver Second by detecting differences between the LDS in patients with PAH and control subjects
One of the objectives of the present study is to evaluate the lung Doppler signals in pediatric patients of various age groups with and without pulmonary vascular disease The second objective of the study is to verify previous findings of abnormal lung Doppler signals in adult patients with pulmonary hypertension
Pulmonary arterial hypertension PAH is a condition characterized by reshaping of the small pulmonary arteries with increase in pulmonary vascular resistance leading gradually to right-sided cardiac failure A trans-thoracic echocardiograph TTE is a test classically undertaken in order to screen for pulmonary hypertension However the systolic pulmonary artery pressure SPAP values thereby obtained are often imprecise and depend upon the expertise of the individual carrying out the test Therefore the pulmonary arterial pressure and cardiac output values have to be ascertained with a right-sided cardiac catheterization which is considered the gold-standard but is invasive
In a pilot study of adult PAH patients unpublished lung Doppler signals have been shown to have the potential to diagnose pulmonary hypertension in two different ways First by measuring the degree of attenuation of the LDS during acute pressure rise in the chest cavity ie during Valsalva maneuver Second by detecting differences between the LDS in patients with PAH and control subjects
One of the objectives of the present study is to evaluate the lung Doppler signals in pediatric patients of various age groups with and without pulmonary vascular disease The second objective of the study is to verify previous findings of abnormal lung Doppler signals in adult patients with pulmonary hypertension
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None