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CNAP in Heart Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01420484
First Posted: August 19, 2011
Last Update Posted: December 19, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
CNSystems Medizintechnik AG
Information provided by (Responsible Party):
Konstanze Plaschke, University of Heidelberg
  Purpose

The role of continuous non-invasive arterial pressure (CNAP) in high risk patients with pronounced variation of arterial pressure will be assessed under analgosedation.

Therefore, patients will be analyzed during normo-, hypo- and hypertension with standard IAP undergoing elective transfemoral aortic valve implantation procedures. Systolic, diastolic, and mean invasive arterial pressures (IAP) will be compared to those obtained by CNAP. Data will be analysed in different periods of arterial pressure for agreement of the two methods and for determination of precision (i.e. measurement error) and accuracy (i.e. systematic error). Additionally, we will compare both methods regarding the amplitude and time of very fast changes in arterial pressure during intervals of functional cardiac arrests (rapid pacing).


Condition Intervention
Transfemoral Implantation of Aortic Valves Other: different blood pressure intervals

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Noninvasive Blood Pressure Measuring

Further study details as provided by Konstanze Plaschke, University of Heidelberg:

Primary Outcome Measures:
  • blood pressure [ Time Frame: blood pressure ]

Secondary Outcome Measures:
  • age [ Time Frame: age ]
    descriptive data


Enrollment: 50
Study Start Date: January 2010
Study Completion Date: December 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
different blood pressure intervals Other: different blood pressure intervals
In differnent blood presure intervals the IAP and CNAP measurement differences will be observed.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients admitted for elective transfemoral implantation of the aortic valve in analgosedation will be included. The patients' primary diagnosis was severe aortic stenosis, that was defined as a valve area of <1cm² or a mean pressure gradient >50mmHg.

Exclusion criteria for the study will be an advanced dysfunction of peripheral perfusion (i.e. pronounced arterial peripheral artery occlusive disease or Raynaud's syndrome), arterio-venous shunts for haemodialysis, and vascular surgery of the upper extremities.

Before including patients in the present study, blood pressure will be measured on both arms noninvasively by oscillometry to exclude any significant arterial stenosis between the upper extremities. Differences of less than 10 mmHg will be accepted.

All patients won't receive any sedative drugs preoperatively and were allowed to drink fluids up to 2 hours before surgery.

Criteria

Inclusion Criteria:

  • Patients admitted for elective transfemoral implantation of the aortic valve in analgosedation will be included.
  • The patients' primary diagnosis was severe aortic stenosis, that was defined as a valve area of <1cm² or a mean pressure gradient >50mmHg.

Exclusion Criteria:

  • an advanced dysfunction of peripheral perfusion (i.e. pronounced arterial peripheral artery occlusive disease or Raynaud's syndrome)
  • arterio-venous shunts for haemodialysis, and vascular surgery of the upper extremities
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01420484


Locations
Germany
Medical Clinic, University of heidelberg
Heidelberg, Germany, D-69120
Sponsors and Collaborators
Heidelberg University
CNSystems Medizintechnik AG
Investigators
Principal Investigator: Christoph Schramm, MD Department of Anesthesiology
  More Information

Responsible Party: Konstanze Plaschke, PhD, University of Heidelberg
ClinicalTrials.gov Identifier: NCT01420484     History of Changes
Other Study ID Numbers: S234/2009
First Submitted: August 18, 2011
First Posted: August 19, 2011
Last Update Posted: December 19, 2013
Last Verified: December 2013

Keywords provided by Konstanze Plaschke, University of Heidelberg:
CNAP
continuous non-invasive arterial pressure
IAP
blood pressure
analgosedation
high-risk patients
rapid-pacing