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Trial record 39 of 129 for:    PAP children

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

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ClinicalTrials.gov Identifier: NCT01913457
Recruitment Status : Recruiting
First Posted : August 1, 2013
Last Update Posted : July 25, 2018
Sponsor:
Information provided by (Responsible Party):
Echosense Ltd.

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In a pilot study of adult PAH patients (unpublished), lung Doppler signals have been shown to have the potential to diagnose pulmonary hypertension in two different ways: First, by measuring the degree of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

Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Evaluation of Lung Doppler Signals in Pediatric and Adult Patients
Study Start Date : July 2013
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


Group/Cohort 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




Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01913457


Contacts
Contact: Jeffrey Feinstein, MD (650) 723-7913 jeff.feinstein@stanford.edu
Contact: Roham Zamanian, MD (650) 723-8922 roham.zamanian@stanford.edu

Locations
United States, California
Stanford Hospital and Clinics and Lucile Packard Children's Hospital Recruiting
Palo Alto, California, United States
Contact: Jeffrey Feinstein, MD    650-723-7913    jeff.feinstein@stanford.edu   
Sub-Investigator: Danielle Burstein, MD         
Stanford university hospital Recruiting
Palo Alto, California, United States
Sponsors and Collaborators
Echosense Ltd.
Investigators
Principal Investigator: Jeffery Feinstein, MD Stanford Hospital and Clinics and Lucile Packard Children's Hospital

Responsible Party: Echosense Ltd.
ClinicalTrials.gov Identifier: NCT01913457     History of Changes
Other Study ID Numbers: DOP018/25388
First Posted: August 1, 2013    Key Record Dates
Last Update Posted: July 25, 2018
Last Verified: March 2017

Keywords provided by Echosense Ltd.:
Ultrasound Doppler
Lungs
Pulmonary artery hypertension

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases