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
120
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