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

March 22, 2022 updated by: Echosense Ltd.

Evaluation of Lung Doppler Signals in Pediatric and Adult Patients

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In a pilot study of adult PAH patients (unpublished), lung Doppler signals have been shown to have the potential to diagnose pulmonary hypertension in two different ways: First, by measuring the degree of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

Study Overview

Status

Terminated

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

230

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Palo Alto, California, United States
        • Stanford University Hospital
      • Palo Alto, California, United States
        • Stanford Hospital and Clinics and Lucile Packard Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study targets to enroll 200 patients (see inclusion criteria): 100 patients will be children without cardiopulmonary diseases, 50 patients will be children undergoing heart catheterization, 50 patients will be adults undergoing heart catheterization

Description

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:

    a. Any contra-indication to perform the procedure

  • For adults only:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Diagnose specific pattern of LDS in children by features as velocity & power in comparison to adult LDS pattern.
Time Frame: 1 year to collect all data and obtain an average diagnostic pattern
1 year to collect all data and obtain an average diagnostic pattern

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Jeffery Feinstein, MD, Stanford Hospital and Clinics and Lucile Packard Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2013

Primary Completion (Actual)

July 1, 2021

Study Completion (Actual)

July 1, 2021

Study Registration Dates

First Submitted

July 25, 2013

First Submitted That Met QC Criteria

July 30, 2013

First Posted (Estimate)

August 1, 2013

Study Record Updates

Last Update Posted (Actual)

March 23, 2022

Last Update Submitted That Met QC Criteria

March 22, 2022

Last Verified

June 1, 2019

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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