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Comparison of Continuous Non-invasive Arterial Pressure (CNAP) With Invasive Arterial Pressure Monitoring

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Robert Hanss, University of Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT01003665
First received: October 28, 2009
Last updated: April 13, 2012
Last verified: April 2012

October 28, 2009
April 13, 2012
February 2009
May 2010   (final data collection date for primary outcome measure)
Bias and percentage error of CNAP compared with invasive arterial pressure measurement [ Time Frame: 1.) Induction of general anaesthesia. 2.) Maintanance of general anaesthesia. 3.) Intensive Care Treatement after surgery ] [ Designated as safety issue: No ]
Bias and percentage error of CNAP compared with IBP [ Time Frame: perioperative ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01003665 on ClinicalTrials.gov Archive Site
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Comparison of Continuous Non-invasive Arterial Pressure (CNAP) With Invasive Arterial Pressure Monitoring
Accuracy of the CNAP™ Monitor (Continuous Non-invasive Arterial Pressure) Versus Invasive Radial Arterial Monitoring in Surgical Patients

The purpose of this study was to compare the Continuous Non-invasive Arterial Pressure (CNAP) monitor with the gold standard of invasive arterial pressure monitoring during:

  1. induction and maintenance of general anaesthesia
  2. intensive care unit treatment of postoperative patients with an ASA 3 or 4 status

The CNAP monitor continuously measures blood pressure using a finger cuff. It showed a good agreement to invasive blood pressure measurements during anaesthesia induction and maintenance during surgery. In critical ill patients cardiac arrhythmia is probably a confounding factor affecting accuracy and interchangeability of CNAP. As systolic arterial CNAP pressure in comparison to mean pressure shows no statistical interchangeability with invasive measurements, mean pressure should be considered when making therapy decisions.

A problem is the missing standard criterion for comparison of continuously devices with invasive pressure.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Probability Sample

patients undergoing major surgery or intensive care unit treatement with the need for an invasive blood pressure measurement

Blood Pressure
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Intensive Care treatement
ASA status 3 or 4 patients with invasive blood pressure measurement on the intensive care unit
Ilies C, Bauer M, Berg P, Rosenberg J, Hedderich J, Bein B, Hinz J, Hanss R. Investigation of the agreement of a continuous non-invasive arterial pressure device in comparison with invasive radial artery measurement. Br J Anaesth. 2012 Feb;108(2):202-10. doi: 10.1093/bja/aer394. Epub 2011 Dec 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
195
January 2012
May 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age >18
  • BMI < 35 kg.m²
  • Patients capable of giving informed consent
  • patients undergoing elective surgical procedures in supine position under general anesthesia
  • perfusion of the examined arm evidenced by a positive Allen's test

Exclusion Criteria:

  • Patients not competent or unwilling to provide informed consent
  • Patients with history of neurological, neuromuscular seizure
  • Patients where IBP cannula, CNAP™ finger-cuff and CNAP™ upper arm cuff cannot be placed on the same arm
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01003665
CNAP-2009-1
No
Robert Hanss, University of Schleswig-Holstein
University of Schleswig-Holstein
Not Provided
Study Chair: Markus Steinfath, Professor Klinik für Anästhesiologie und Operative Intensivmedizin, UKSH Kiel
Study Director: Robert Hanss, Professor Klinik für Anästhesiologie und Operative Intensivmedizin, UKSH Kiel
University of Schleswig-Holstein
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP