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

Pulmonary Arterial Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01357746
• Other study ID #: DOPO8
• Status: Terminated
• Phase: Phase 1
• First received: May 17, 2011
• Last updated: August 17, 2013
• Start date: July 2011

Study information

• Verified date: May 2011
• Source: Echosense Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Hypertension
• Pulmonary Arterial Hypertension

Intervention

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

Locations

Country	Name	City	State
Israel	Department of Cardiology, Rambam Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Echosense Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reaching target enrollment number	Enrollment of 60 valid patients	1-2 years	No
Secondary	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	Yes