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

Brief Title

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

Official Title

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

Brief Summary

      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

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

Primary Outcome

Accuracy and precision of blood pressure and cardiac output by applanation tonometry

Secondary Outcome

 Trending ability of blood pressure monitoring by applanation tonometry

Condition

Atrial Fibrillation

Study Arms / Comparison Groups

 Patients with atrial fibrillation

Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Estimated Enrollment

Start Date

June 2015

Completion Date

December 2016

Primary Completion Date

June 2016

Eligibility Criteria

        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

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Daniel Reuter, , [email protected]

Location Countries

Germany

Location Countries

Germany

Administrative Informations

NCT ID

NCT02444104

Organization ID

TNSYS2015

Responsible Party

Sponsor

Study Sponsor

Universitätsklinikum Hamburg-Eppendorf

Study Sponsor

Daniel Reuter, Study Director, University Hamburg

Verification Date

October 2015