CNAP in Heart Surgery

Completed

• Conditions: Transfemoral Implantation of Aortic Valves

• Registration Number: NCT01420484
• Lead Sponsor: Heidelberg University

Brief Summary

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

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2011-08-18
• Study First Submitted QC: 2011-08-18
• Study First Posted: 2011-08-19
• Primary Completion: 2013-10
• Status Verified: 2013-12
• Study Completion: 2013-12
• Last Update Submitted: 2013-12-18
• Last Update Posted: 2013-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
blood pressure	blood pressure

Secondary Outcome Measures

Name	Time	Method
age	age	descriptive data

Trial Locations

Locations (1)

Medical Clinic, University of heidelberg; 🇩🇪 Heidelberg, Germany