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Continuous Non-invasive Arterial Pressure (CNAP): Assessment in High-risk Patients Under Analgosedation, Role of Rapid Pacings

This study is currently recruiting participants.
Verified February 2012 by University of Heidelberg
Sponsor:
Collaborator:
CNSystems Medizintechnik AG
Information provided by (Responsible Party):
Konstanze Plaschke, University of Heidelberg
ClinicalTrials.gov Identifier:
NCT01420484
First received: August 18, 2011
Last updated: February 13, 2012
Last verified: February 2012
History of Changes
  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

Further study details as provided by University of Heidelberg:

Estimated Enrollment: 50
Study Start Date: January 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: October 2012 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01420484

Contacts
Contact: Konstanze PLASCHKE, pROF: -49-6221-566451 konstanze.plaschke@med.uni-heidelberg.de

Locations
Germany
Medical Clinic, University of heidelberg Recruiting
Heidelberg, Germany, D-69120
Contact: Christoph Schramm, MD     -40-6221-5638545     christoph.schramm@med.uni-heidelberg.de    
Sponsors and Collaborators
University of Heidelberg
CNSystems Medizintechnik AG
Investigators
Principal Investigator: Christoph Schramm, MD Department of Anesthesiology
  More Information

No publications provided

Responsible Party: Konstanze Plaschke, PhD, University of Heidelberg
ClinicalTrials.gov Identifier: NCT01420484     History of Changes
Other Study ID Numbers: S234/2009
Study First Received: August 18, 2011
Last Updated: February 13, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on May 23, 2013