Clinical Trials

Non-Invasive Acoustic Estimation of the Pulmonary Artery Pressure

Study Description

This is a prospective, descriptive, physician initiated, single center study conducted at the University of Utah Health Sciences Center [UUHSC] and the Salt Lake City Veterans Administration Health Care System [VASLCHCS].

Pulmonary artery pressure (PAP) is a very useful parameter for the clinical evaluation of many cardiac diseases. Pulmonary hypertension is a frequent and serious complication of many cardiovascular and pulmonary diseases. As the options for treatment of pulmonary hypertension have expanded, the requirement for accurate and non-invasive methods to allow regular and safe estimation of pulmonary arterial pressure (PAP) has increased. Consequently, it would be useful to develop other non-invasive methods to allow frequent and accurate measurement of PAP. Recently, it has been shown that acoustic cardiography, specifically the characteristics of the second heart sound, may be used to estimate the PAP.

We hope to prove that PAP can be accurately measured with the Audicor machine [EKG with sound leads that will provide acoustic data] so that the patient does not have to undergo a Right Heart Catheterization to obtain this pressure measurement.

The study takes about 10-15 mins.  We plan to enroll 50 patients; both inpatients and outpatients referred for right heart catheterization. For patients undergoing right heart catheterization, this recording will be done before patient's catheterization. For ICU inpatients with a Swan-Ganz catheter inserted, acoustic data can be collected at any time.  Access to the patient’s prior echocardiographic data will be sought.

Contact Information

Status:

Name, Phone, Email:
Renee Neuharth, BS
801-587-4877
Renee.Neuharth@hsc.utah.edu

Principle Investigator:
Shadi Karabsheh, MD

Please Note:

Faculty Sponsor: Andrew D. Michaels, MD, MAS, FACC, FAHA

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Participant Eligibility

Inclusion Criteria:

All adult patients referred for right heart catheterization at the UUHSC and the VASLCHCS. Intensive care unit inpatients with a Swan-Ganz pulmonary artery catheter inserted are eligible for inclusion. Patients will have the opportunity to participate in the study regardless of sex or ethnicity, race or socioeconomic class. Pregnant women, prisoners and patients with AIDS will also be included. The number of patients enrolled prospectively will be set at fifty.

Exclusion Criteria:

Patients who are unable to give consent will be excluded if they do not have one of the following persons to give consent on their behalf:

  • Spouse
  • Adult (18 years of age or over) for his or her parent
  • Individual with power of attorney
  • Guardian appointed to make medical decisions for individuals who are incapacitated.

ICU inpatients with a Swan-Ganz catheter inserted in them who are hemodynamically unstable, those with a high degree of noise in the vicinity of their chest (e.g. positive pressure ventilation) and those with an inaccessible chest area (due to infection, recent surgery or accident, burn) will be excluded. 

How long does the study run?

June 2008

Location(s) of the Clinical Trial

University of Utah Health Sciences Center and Veterans Affairs Medical Center