CNAP in Heart Surgery

Heidelberg University

Status: Completed

Conditions: Transfemoral Implantation of Aortic Valves

Treatments: Other: different blood pressure intervals

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01420484

S234/2009

Details and patient eligibility

About

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).

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

different blood pressure intervals

Treatment:

Other: different blood pressure intervals