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

This study has been completed.

First Received on October 28, 2009. Last Updated on July 6, 2010 History of Changes

Sponsor:	University of Schleswig-Holstein
Information provided by:	University of Schleswig-Holstein
ClinicalTrials.gov Identifier:	NCT01003665

Purpose

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.

Condition
Blood Pressure

Study Type:	Observational
Study Design:	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

Further study details as provided by University of Schleswig-Holstein:

Primary Outcome Measures:

Bias and percentage error of CNAP compared with IBP [ Time Frame: perioperative ] [ Designated as safety issue: No ]

Enrollment:	85
Study Start Date:	February 2009
Study Completion Date:	May 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

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 although a standard criterion for comparison of continuously devices with invasive pressure is missing.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

patients undergoing major surgery with the need for an invasive blood pressure measurement

Criteria

Inclusion Criteria:

Age >18
ASA I, II orIII
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01003665

Locations

Germany
Klinik für Anästhesiologie und Operative Intensivmedizin, Universitätsklinik Schleswig-Holstein, Campus Kiel
Kiel, Germany, 24106

Sponsors and Collaborators

University of Schleswig-Holstein

Investigators

Study Chair:	Markus Steinfath, Prof.	Klinik für Anästhesiologie und Operative Intensivmedizin, UKSH Kiel
Principal Investigator:	Robert Hanss, PD Dr. med.	Klinik für Anästhesiologie und Operative Intensivmedizin, UKSH Kiel

More Information

No publications provided

Responsible Party:	Robert Hanss PD Dr. med., Klinik Anästhesiologie und Operative Intensivmedizin
ClinicalTrials.gov Identifier:	NCT01003665 History of Changes
Other Study ID Numbers:	CNAP-2009-1
Study First Received:	October 28, 2009
Last Updated:	July 6, 2010
Health Authority:	Germany: Ministry of Health

ClinicalTrials.gov processed this record on February 09, 2012