Evaluation of Blood Flow Patterns in Lung Blood Vessels Using Ultrasound Technique in Patients With Congestive Heart Failure

Evaluation of Pulmonary Blood Flow Patterns Using Transthoracic Doppler in Patients With Congestive Heart Failure

Historically, transthoracic Doppler echocardiography has been unable to provide interpretable data of blood flow within the lung parenchyma because of air attenuation of Doppler signals. Recently, a transthoracic Doppler system known as the Sonara/tek Transcranial Doppler (TCD) System has been developed that can identify parenchymal pulmonary blood flow (PPBF) signals. The ability to non-invasively collect information regarding the pulmonary aspect of the cardio-pulmonary system may provide valuable information and new insights into the structural and functional characteristics of the lung parenchyma and vasculature in health and disease states.

Study Overview

• Status: Withdrawn
• Conditions: Congestive Heart Failure (CHF)

Detailed Description

This new system was previously studied among 31 healthy volunteers and one subject with atrial fibrillation.1 Pulsed spectral Doppler signals were obtained over the chest wall using a signal processing and algorithm package in conjunction with a non-imaging Doppler device coupled with an electrocardiogram. Clear reproducible lung Doppler signals (LDS) originating from different elements and phases of cardiac activity that generate mechanical waves which propagate throughout the lung were expressed in pulsatile changes in ultrasound reflections.

After the completion of the first 25 patients in our pilot study, we have received some valuable information. After assessing patients with CHF and pulmonary hypertension, we identified signals particular to the CHF group. There were unique features that were never observed in the normal patients. On top of the regular Lung Doppler signals seen in normal patients, high velocity "disorganized" variable signals that were not synchronous with the heart beat, but rather sometimes with respiration were observed. We believe that the signals may represent popping open of small bronchi surrounded by "water filled" parenchyma. These events that generate very strong reflector like signals may represent the movement of fluid at the blood vessel-alveolar air junction.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • New York
    • New-York, New York, United States, 10075
      • NSLIJ Lenox Hill hospital, 100East 77 Street

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

CHF patients admitted to the cardiology telemetry unit and to the CCU

Description

Inclusion Criteria:

• Inclusion criteria

  1. Age over 50 years

  2. Belongs to one of the following categories:

     A. Decompensated CHF: patients with overt pulmonary congestion or pulmonary edema on admission, evident both clinically and by chest x-ray. Patients may be with or without a Swan-Ganz catheter.

     B. Compensated CHF: patients with significant CHF (NYHA II-IV) who are well controlled and without evidence of pulmonary congestion or pulmonary edema on admission.

     C. Non-CHF controls: patients without CHF and without any of the following: pulmonary hypertension, any known pulmonary disease, uncontrolled hypertension.

  3. Signed Informed Consent

Exclusion Criteria:

• Chronic obstructive pulmonary disease (COPD) Asthma Interstitial lung disease Any other obstructive or restrictive lung diseases Pneumonia- currently or in the past 3 months prior to inclusion Current or past pulmonary embolism Non-cardiogenic pulmonary edema or lung injury (e.g. ARDS) Right sided pleural effusion that is not mild Severe kyphosis, scoliosis or chest wall deformity

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
CHF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnose specific patterns of doppler signals in CHF patients	Comparing Doppler signals' features as velocity, power, timimg, slopes and other between CHF patients and non-CHF patients. Participants will be followed up for the duration of hospital stay, usuall up to 1 week.	December 2013

Collaborators and Investigators

• Sponsor: Echosense Ltd.

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (ANTICIPATED): April 1, 2015
• Study Completion (ANTICIPATED): July 1, 2015

Study Registration Dates

• First Submitted: December 2, 2012
• First Submitted That Met QC Criteria: December 5, 2012
• First Posted (ESTIMATE): December 6, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): June 26, 2014
• Last Update Submitted That Met QC Criteria: June 24, 2014
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: DOP081412