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CNAP in Heart Surgery

NCT ID: NCT01420484

Last Updated: 2013-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Transfemoral Implantation of Aortic Valves

Keywords

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CNAP continuous non-invasive arterial pressure IAP blood pressure analgosedation high-risk patients rapid-pacing

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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different blood pressure intervals

different blood pressure intervals

Intervention Type OTHER

In differnent blood presure intervals the IAP and CNAP measurement differences will be observed.

Interventions

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different blood pressure intervals

In differnent blood presure intervals the IAP and CNAP measurement differences will be observed.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CNSystems Medizintechnik AG

INDUSTRY

Sponsor Role collaborator

Heidelberg University

OTHER

Sponsor Role lead

Responsible Party

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Konstanze Plaschke

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christoph Schramm, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology

Locations

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Medical Clinic, University of heidelberg

Heidelberg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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S234/2009

Identifier Type: -

Identifier Source: org_study_id