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

August 18, 2011
December 18, 2013
January 2010
October 2013   (final data collection date for primary outcome measure)
blood pressure [ Time Frame: blood pressure ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT01420484 on ClinicalTrials.gov Archive Site
age [ Time Frame: age ] [ Designated as safety issue: No ]
descriptive data
Not Provided
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CNAP in Heart Surgery
Noninvasive Blood Pressure Measuring

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).

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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.

Transfemoral Implantation of Aortic Valves
Other: different blood pressure intervals
In differnent blood presure intervals the IAP and CNAP measurement differences will be observed.
different blood pressure intervals
Intervention: Other: different blood pressure intervals
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
December 2013
October 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01420484
S234/2009
No
Konstanze Plaschke, University of Heidelberg
Heidelberg University
CNSystems Medizintechnik AG
Principal Investigator: Christoph Schramm, MD Department of Anesthesiology
Heidelberg University
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP