Clinical trial NCT01357746: Measuring Blood Pressure in the Lung Circulation With Sonar Technology (Echo-Doppler)
Official title: Detection, Estimation and Characterization of Pulmonary Blood Pressure by Transthoracic Parametric Doppler (TPD)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Pulmonary Arterial Hypertension
Keywords: Pulmonary arterial blood pressure doppler
Lead sponsor: Echosense Ltd.
Sponsor class: INDUSTRY
First posted: 2011-05-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Reaching target enrollment number
timeFrame: 1-2 years
Secondary outcomes:
measure: Lack of adverse effects
timeFrame: 1-2 years
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Department of Cardiology, Rambam Medical Center
Study officials:
affiliation: Rambam Health Care Campus
name: Robert Dragu, MD
role: PRINCIPAL_INVESTIGATOR
References: