Measuring Blood Pressure in the Lung Circulation With Sonar Technology (Echo-Doppler)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01357746
Recruitment Status : Terminated (Low recruitment)
First Posted : May 23, 2011
Last Update Posted : August 20, 2013
Information provided by:
Echosense Ltd.

Brief Summary:

This is a non-invasive study using a standard doppler echocardiographic transducer which records signals emanating from the lungs (TPD). These signals are caused by pulsation of blood vessels in the lung tissue.

The innovations in this study are:

  1. The software processing of the reflected ultra-sound waves from the lung rendering a reproducible, clear and strong signal in sync with the cardiac cycle,
  2. The observation based on pilot studies that blowing hard against resistance during recording (something called a Valsalva maneuver), affects the lung signal weakening it and even obliterating it as the pressure rises.

The investigators hypothesis is that since the signal comes from the blood vessels in the lung, the pressure at which the recorded signal disappears during the Valsalva maneuver represents the blood pressure in the lungs.

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Procedure: Transthoracic pulmonary doppler recording Phase 1

Detailed Description:

Current methods for noninvasive measurement of pulmonary arterial blood pressure by standard echo-doppler equipment are fraught with uncertainty. So much so that patients being screened and followed for pulmonary arterial hypertension require right heart catheterization. An invasive and uncomfortable and potentially dangerous procedure.

This study is designed to confirm our preliminary observation that there is good correlation between Valsalva maneuver pressure and pulmonary arterial blood pressure.

Sixty patients undergoing right heart catheterization for clinical reasons will be studied.

The study itself is short, about 30 minutes, painless and done with the patient either sitting up in bed or semi-reclining. The probe is positioned over the right chest wall and the patient is requested to successively blow into a mouthpiece at rising pressures, to tolerance.

The results obtained using TPD to asses pulmonary arterial pressure will be compared to the results obtained at catheterization.

This is part of the development phase of the technology.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Detection, Estimation and Characterization of Pulmonary Blood Pressure by Transthoracic Parametric Doppler (TPD)
Study Start Date : July 2011
Actual Primary Completion Date : June 2012

Intervention Details:
    Procedure: Transthoracic pulmonary doppler recording
    A 30 min recording of doppler signals from the right chest wall including measurements while the patient performs Valsalva maneuvers

Primary Outcome Measures :
  1. Reaching target enrollment number [ Time Frame: 1-2 years ]
    Enrollment of 60 valid patients

Secondary Outcome Measures :
  1. Lack of adverse effects [ Time Frame: 1-2 years ]
    No adverse effects are expected but since this is a new application of old technolology safety is a possible issue.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:


  • Age 18 years or older
  • Patients who are clinically suspected of having elevated pulmonary blood pressure , due to cardiac or cardio-pulmonary disease preferably any one or more of the conditions listed below, and due to have right heart catheterization as part of the diagnostic work-up:
  • Patients with CHF
  • Patients with primary pulmonary arterial hypertension
  • Patients with COPD
  • Patients with asthma
  • Patients with interstitial lung disease
  • Patients with sarcoidosis
  • Signed informed consent.

Exclusion Criteria:

  • Patients unable to cooperate.
  • Inability to assume a sitting or supine position
  • Patients with severe chest wall deformity

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 identifier (NCT number): NCT01357746

Department of Cardiology, Rambam Medical Center
Haifa, Israel, 35254
Sponsors and Collaborators
Echosense Ltd.
Principal Investigator: Robert Dragu, MD Rambam Health Care Campus

Responsible Party: RACHEL SCHATZBERGER/CHIEF SCIENTIFIC OFFICER, Echosense Ltd. Identifier: NCT01357746     History of Changes
Other Study ID Numbers: DOPO8
First Posted: May 23, 2011    Key Record Dates
Last Update Posted: August 20, 2013
Last Verified: May 2011

Keywords provided by Echosense Ltd.:
Pulmonary arterial blood pressure doppler

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