CNAP in Heart Surgery

Noninvasive Blood Pressure Measuring

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01420484

Enrollment

Registered

2011-08-19

Start date

2010-01-31

Completion date

2013-12-31

Last updated

2013-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transfemoral Implantation of Aortic Valves

Keywords

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

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).

Interventions

OTHERdifferent blood pressure intervals

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
blood pressure	blood pressure

Secondary

Measure	Time frame	Description
age	age	descriptive data

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026