Skip to main content
OpenTrials
Completed

NCT Number: NCT01420484

CNAP in Heart Surgery

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Transfemoral Implantation of Aortic Valves

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical Clinic, University of heidelberg

Heidelberg, D-69120, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

different blood pressure intervals

Other

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

Primary outcomes

  1. blood pressure

    Time frame: blood pressure

Secondary outcomes

  1. age

    Time frame: age

    descriptive data

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Collaborators

  • CNSystems Medizintechnik AG

Registry information

Official study title

Noninvasive Blood Pressure Measuring

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Aug 19, 2011
Registry last updated
Dec 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.