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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01003665
Recruitment Status : Completed
First Posted : October 29, 2009
Last Update Posted : April 16, 2012
Information provided by (Responsible Party):
Robert Hanss, University of Schleswig-Holstein

Brief Summary:

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

Condition or disease
Blood Pressure

Detailed Description:

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.

Study Type : Observational
Actual Enrollment : 195 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Accuracy of the CNAP™ Monitor (Continuous Non-invasive Arterial Pressure) Versus Invasive Radial Arterial Monitoring in Surgical Patients
Study Start Date : February 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : January 2012

Intensive Care treatement
ASA status 3 or 4 patients with invasive blood pressure measurement on the intensive care unit

Primary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients undergoing major surgery or intensive care unit treatement with the need for an invasive blood pressure measurement

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01003665

Klinik für Anästhesiologie und Operative Intensivmedizin, Universitätsklinik Schleswig-Holstein, Campus Kiel
Kiel, Germany, 24106
Sponsors and Collaborators
University of Schleswig-Holstein
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