CNAP in Heart Surgery

December 18, 2013 updated by: Konstanze Plaschke, Heidelberg University

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Heidelberg, Germany, D-69120
        • Medical Clinic, University of heidelberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
different blood pressure intervals
Other: different blood pressure intervals
In differnent blood presure intervals the IAP and CNAP measurement differences will be observed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
blood pressure
Time Frame: blood pressure
blood pressure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
age
Time Frame: age
descriptive data
age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidelberg University

Collaborators

CNSystems Medizintechnik AG

Investigators

  • Principal Investigator: Christoph Schramm, MD, Department of Anesthesiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

August 18, 2011

First Submitted That Met QC Criteria

August 18, 2011

First Posted (Estimate)

August 19, 2011

Study Record Updates

Last Update Posted (Estimate)

December 19, 2013

Last Update Submitted That Met QC Criteria

December 18, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • S234/2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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