CNAP in Heart Surgery

This study has been completed.
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: December 18, 2013
Last verified: December 2013
  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 Heidelberg University:

Primary Outcome Measures:
  • blood pressure [ Time Frame: blood pressure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • age [ Time Frame: age ] [ Designated as safety issue: No ]
    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

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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

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: December 18, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on July 22, 2014