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Clinical Trials/NCT01623986
NCT01623986
Completed
Not Applicable

Technical Correlation of a Noninvasive Estimation of Central Venous Pressure From the Mespere Venus 1000 System and the Inferior Vena Cava From Echocardiography, to Estimate Right Atrial Pressure

Mespere Lifesciences Inc.1 site in 1 country45 target enrollmentMarch 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Patients Referred to St. Michael's Hospital Echocardiography Lab
Sponsor
Mespere Lifesciences Inc.
Enrollment
45
Locations
1
Primary Endpoint
Right atrial pressure (RAP)
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

The purpose of this clinical study is to investigate if central venous pressure (CVP) measurements from the Mespere Venus 1000 System can be used for right atrial pressure (RAP) when estimating right ventricular systolic pressure (RVSP) in echocardiography labs.

Detailed Description

The non-invasive assessment of the pressure on the right side of your heart using an imaging machine called a Doppler echocardiography machine (also known as an ECHO machine) is a widely accepted technique and is used as a screening tool for pulmonary hypertension and heart failure. The pressure on this side of your heart reflects the pressure of the blood in your veins returning to your heart and the effectiveness of your heart to pump that blood to your lungs. The accuracy of this technique depends on making an accurate estimate of the pressure in the upper chamber (atrium) of the right side of your heart, known as your right atrial pressure (RAP). Right atrium pressure can be measured non-invasively by imaging of your heart using an echocardiography (aka ECHO) machine. But the technique depends on the skills of the sonographer (the person who operates the ECHO machine) and can take considerable time to complete. In view of this limitation, a non-invasive technique that could be used to make the RAP measurements may be more reliable and/or faster than the current technique. Mespere Lifesciences Inc. has developed a new non-invasive device that is expected to allow for a simple, rapid and reliable measurement of RAP. The device consists of a set of light sensors on a patch that is placed onto the surface of the patient's right side of the neck.

Registry
clinicaltrials.gov
Start Date
March 2013
End Date
September 2013
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age 18 and older
  • Patient referred to St. Michael's Hospital Echocardiography Lab
  • Signed written and informed consent

Exclusion Criteria

  • Lack of patient consent
  • Presence of known AV dialysis fistula
  • Allergy to adhesive tape from Mespere Venus 1000 system
  • Known central vein stenosis
  • Unable to identify right external jugular vein
  • Ongoing photodynamic therapy
  • Assisted ventilation

Outcomes

Primary Outcomes

Right atrial pressure (RAP)

Time Frame: 0-1 hour

To determine if the RAP from the non-invasive Mespere Venus 1000 System correlates with the RAP from an echocardiography (ECHO) machine

Study Sites (1)

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