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

NCT02444104 | Unknown

• 1 other identifier: TNSYS2015
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Atrial Fibrillation; Left Ventricular Failure; Left Ventricular Impaired Function; Aortic Valve Stenosis

Keywords

Left Ventricular Assist Device

Outcome Measures

Primary Outcomes (1)

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

  30 minutes

Secondary Outcomes (1)

• Trending ability of blood pressure monitoring by applanation tonometry

  30 minutes

Study Arms (4)

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, Germany

RECRUITING

Related Publications (7)

• Saugel B, Reuter DA. Are we ready for the age of non-invasive haemodynamic monitoring? Br J Anaesth. 2014 Sep;113(3):340-3. doi: 10.1093/bja/aeu145. Epub 2014 May 31. No abstract available.

  PMID: 24880826 BACKGROUND

• Mandel MA, Dauchot PJ. Radial artery cannulation in 1,000 patients: precautions and complications. J Hand Surg Am. 1977 Nov;2(6):482-5. doi: 10.1016/s0363-5023(77)80030-0.

  PMID: 925335 BACKGROUND

• Russell JA, Joel M, Hudson RJ, Mangano DT, Schlobohm RM. Prospective evaluation of radial and femoral artery catheterization sites in critically ill adults. Crit Care Med. 1983 Dec;11(12):936-9. doi: 10.1097/00003246-198312000-00007.

  PMID: 6641252 BACKGROUND

• Weiser TG, Regenbogen SE, Thompson KD, Haynes AB, Lipsitz SR, Berry WR, Gawande AA. An estimation of the global volume of surgery: a modelling strategy based on available data. Lancet. 2008 Jul 12;372(9633):139-144. doi: 10.1016/S0140-6736(08)60878-8. Epub 2008 Jun 24.

  PMID: 18582931 BACKGROUND

• Reuter DA, Huang C, Edrich T, Shernan SK, Eltzschig HK. Cardiac output monitoring using indicator-dilution techniques: basics, limits, and perspectives. Anesth Analg. 2010 Mar 1;110(3):799-811. doi: 10.1213/ANE.0b013e3181cc885a.

  PMID: 20185659 BACKGROUND

• Saugel B, Trepte CJ, Heckel K, Wagner JY, Reuter DA. Hemodynamic management of septic shock: is it time for "individualized goal-directed hemodynamic therapy" and for specifically targeting the microcirculation? Shock. 2015 Jun;43(6):522-9. doi: 10.1097/SHK.0000000000000345.

  PMID: 25643016 BACKGROUND

• Saugel B, Meidert AS, Hapfelmeier A, Eyer F, Schmid RM, Huber W. Non-invasive continuous arterial pressure measurement based on radial artery tonometry in the intensive care unit: a method comparison study using the T-Line TL-200pro device. Br J Anaesth. 2013 Aug;111(2):185-90. doi: 10.1093/bja/aet025. Epub 2013 Mar 13.

  PMID: 23491946 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation; Heart Failure; Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction

Study Officials

• Daniel Reuter

  University Hamburg

  STUDY DIRECTOR

Central Study Contacts

Sebastian Haas

CONTACT

s.haas@uke.de

Daniel Reuter

CONTACT

dreuter@uke.de

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2015
• First Posted: May 14, 2015
• Study Start: June 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 12, 2015

Record last verified: 2015-10

Locations

DE (1)