Non-invasive Blood Pressure and Cardiac Output Measurement by Using Applanation Tonometry

October 9, 2015 updated by: Universitätsklinikum Hamburg-Eppendorf

Validation of Non-invasive Blood Pressure and Cardiac-output Measurement by Using Applanation Tonometry in Cardiological Patients

To evaluate and to validate accuracy, precision and trending ability of blood pressure and cardiac output measurement by applanation tonometry in cardiological patients having:

  • atrial fibrillation
  • severe impaired leftventricular function
  • severe aortic valve stenosis
  • patients having left ventricular assist device

Experimental measurement: continuous blood pressure measurement and cardiac output measurement is performed by the T-Line 200 pro device (Tensys Medical Inc., San Diego, USA) Control measurement: gold-standard continuous blood pressure measurement is performed by invasive blood pressure measurement by arterial cannulation and cardiac output reference is assessed by transcardiopulmonary thermodilution

Study Overview

Status

Unknown

Conditions

Detailed Description

Increasing complexity of medical interventions and critical care treatment in an elderly getting population requires precise and accurate hemodynamic monitoring.(1) However, advanced invasive hemodynamic monitoring is often combined with complications by arterial or central venous catheterization. Complications such as vessel harming, infection, cardiac arrhythmias and nervous lesions are likely to occur.(2-4) Therefore, in the past various techniques of minimal- or non-invasive hemodynamic monitoring devices have been evaluated.(5, 6) One of the very promising technique is continuous non-invasive blood pressure monitoring by applanation tonometry. Published data revealed efficacy of this technique. (7) However, ability of this technique remains unclear in patients suffering from cardiological pathologies leading to changing stroke volumes as in arterial fibrillation, to highly reduces stroke volume as in severe impaired left-ventricular function or in severe aortic valve stenosis. Further, ability of applanation tonometry in patients without having pulsatile blood flow such as in patients with left-ventricular assist device remains unclear. Therefore, validation of this technique should be performed in the presented study.

Further development of applanation tonometry including pulse contour analysis now enables assessment of cardiac output. However, till now there is limited data assessing validation cardiac output measurement by this method. Cardiac output validation should also be performed in the planed clinical study.

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany
        • Recruiting
        • University Medical Center Hamburg-Eppendorf
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients enable for study enrollement need to suffer from one of the four cardiological pathologies:

  1. atrial fibrillation,
  2. severe impaired leftventricular function,
  3. severe aortic valve stenosis
  4. patients having left ventricular assist device

All patients have to be clinically monitored by invasive blood pressure assessment and transcardiopulmonary thermodilution.

Description

Inclusion Criteria:

  • atrial fibrillation
  • severe impaired leftventricular function
  • severe aortic stenosis
  • LVAD Patients

Exclusion Criteria:

  • Age <18 years
  • pregnancy
  • patients having blood pressure difference of more than 10 mmHg on both arms (measurement by "Riva-Rocci" before study enrolment)
  • pre-existing on arterial vessels of the arms
  • patients who are not able to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Patients with atrial fibrillation
It is Primarily a comparison of methods , non-invasive measured blood pressure versus invasively measured blood pressure and non-invasively measurement of cardiac output versus invasive cardiac output measurement in patients with atrial fibrillation.
Patients with highly reduced LV function
It is Primarily a comparison of methods , non-invasive measured blood pressure versus invasively measured blood pressure and non-invasively measurement of cardiac output versus invasive cardiac output measurement in patients with a highly reduced left ventricular function (LV function)
Patients with aortic stenosis
It is Primarily a comparison of methods , non-invasive measured blood pressure versus invasively measured blood pressure and non-invasively measurement of cardiac output versus invasive cardiac output measurement in patients with severe aortic stenosis
Patients with LVAD
It is Primarily a comparison of methods , non-invasive measured blood pressure versus invasively measured blood pressure and non-invasively measurement of cardiac output versus invasive cardiac output measurement in patients with left ventricular assist-device (LVAD)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Accuracy and precision of blood pressure and cardiac output by applanation tonometry
Time Frame: 30 minutes
30 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Trending ability of blood pressure monitoring by applanation tonometry
Time Frame: 30 minutes
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Investigators

  • Study Director: Daniel Reuter, University Hamburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

May 11, 2015

First Submitted That Met QC Criteria

May 13, 2015

First Posted (Estimate)

May 14, 2015

Study Record Updates

Last Update Posted (Estimate)

October 12, 2015

Last Update Submitted That Met QC Criteria

October 9, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TNSYS2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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