Measurements and Characterization of Doppler Signals From the Right Chest in Pediatric and Adult Patients

Sponsor

Echosense Ltd. (Industry)

Overall Status

Terminated

CT.gov ID

NCT01913457

Collaborator

(none)

230

Enrollment

Locations

Actual Duration (Months)

115

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

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 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.

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In a pilot study of adult PAH patients (unpublished), lung Doppler signals have been shown to have the potential to diagnose pulmonary hypertension in two different ways: First, by measuring the degree of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 (i.e. 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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Hypertension	Radiation: Ultrasound Doppler

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

230 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Evaluation of Lung Doppler Signals in Pediatric and Adult Patients

Actual Study Start Date :

Jul 1, 2013

Actual Primary Completion Date :

Jul 1, 2021

Actual Study Completion Date :

Jul 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Adults w/ PH Subjects above 18y scheduled to undergo RHC for Doppler ultrasound external right chest wall tests	Radiation: Ultrasound Doppler Doppler Ultrasound recording on external right chest wall
Children w/ PH Children 0-18y old scheduled to RHC	Radiation: Ultrasound Doppler Doppler Ultrasound recording on external right chest wall
Children control Children 0-18y old w/o PH for Lung Doppler tests as controls	Radiation: Ultrasound Doppler Doppler Ultrasound recording on external right chest wall

Arm

Intervention/Treatment

Adults w/ PH

Subjects above 18y scheduled to undergo RHC for Doppler ultrasound external right chest wall tests

Radiation: Ultrasound Doppler

Doppler Ultrasound recording on external right chest wall

Children w/ PH

Children 0-18y old scheduled to RHC

Radiation: Ultrasound Doppler

Doppler Ultrasound recording on external right chest wall

Children control

Children 0-18y old w/o PH for Lung Doppler tests as controls

Radiation: Ultrasound Doppler

Doppler Ultrasound recording on external right chest wall

Outcome Measures

Primary Outcome Measures

Diagnose specific pattern of LDS in children by features as velocity & power in comparison to adult LDS pattern. [1 year to collect all data and obtain an average diagnostic pattern]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Adults undergoing RHC:
Males or females aged over 18 years
With suspicion or diagnosis of pulmonary hypertension.
Scheduled to undergo right heart catheterization
Able and willing to give informed consent

Pediatric patients undergoing RHC:

Males or females aged 0-18 years
Scheduled to undergo right hear catheterization
Parents willing to give informed consent

Pediatric patients without significant cardio-pulmonary diseases:

Males or females aged 0-18 years Not known to have a significant cardiac or pulmonary disease
Legal guardians willing to give informed consent

Exclusion Criteria:

-Hemodynamically unstable patients.
For adult and pediatric patients undergoing right heart catheterization:

Any contra-indication to perform the procedure

For adults only:

Patients incapable of performing a Valsalva maneuver
Patients with recent (within the past 3 months) myocardial infarction, high degree AV block, severe aortic stenosis or open angle glaucoma

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford Hospital and Clinics and Lucile Packard Children's Hospital	Palo Alto	California	United States
2	Stanford university hospital	Palo Alto	California	United States