Clinical trial NCT01420484: CNAP in Heart Surgery
Official title: Noninvasive Blood Pressure Measuring
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transfemoral Implantation of Aortic Valves
Keywords: CNAP
continuous non-invasive arterial pressure
IAP
blood pressure
analgosedation
high-risk patients
rapid-pacing
Lead sponsor: Heidelberg University
Sponsor class: OTHER
Collaborators: name: CNSystems Medizintechnik AG
First posted: 2011-08-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).


Eligibility criteria: 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

Primary outcomes:
measure: blood pressure
timeFrame: blood pressure
Secondary outcomes:
measure: age
timeFrame: age
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Medical Clinic, University of heidelberg
Study officials:
affiliation: Department of Anesthesiology
name: Christoph Schramm, MD
role: PRINCIPAL_INVESTIGATOR
References: