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

NCT ID: NCT01357746

Last Updated: 2013-08-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31

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.

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.

Conditions

Pulmonary Arterial Hypertension

Keywords

Pulmonary arterial blood pressure doppler

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

Transthoracic pulmonary doppler recording

A 30 min recording of doppler signals from the right chest wall including measurements while the patient performs Valsalva maneuvers

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Echosense Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Echosense Ltd.

Principal Investigators

Robert Dragu, MD

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Locations

Department of Cardiology, Rambam Medical Center

Haifa, , Israel

Countries

Israel

Other Identifiers

DOPO8

Identifier Type: -

Identifier Source: org_study_id