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

Detection, Estimation and Characterization of Pulmonary Blood Pressure by Transthoracic Parametric Doppler (TPD)

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.

Study Overview

• Status: Terminated
• Conditions: Pulmonary Arterial Hypertension
• Intervention / Treatment: Procedure: Transthoracic pulmonary doppler recording

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
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel, 35254
    • Department of Cardiology, Rambam Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Eligibility

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reaching target enrollment number	Enrollment of 60 valid patients	1-2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lack of adverse effects	No adverse effects are expected but since this is a new application of old technolology safety is a possible issue.	1-2 years

Collaborators and Investigators

• Sponsor: Echosense Ltd.
• Investigators: Principal Investigator: Robert Dragu, MD, Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: May 17, 2011
• First Submitted That Met QC Criteria: May 20, 2011
• First Posted (Estimate): May 23, 2011

Study Record Updates

• Last Update Posted (Estimate): August 20, 2013
• Last Update Submitted That Met QC Criteria: August 17, 2013
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Keywords: Pulmonary arterial blood pressure doppler
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension, Pulmonary; Hypertension; Pulmonary Arterial Hypertension
• Other Study ID Numbers: DOPO8