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

Blood Pressure Clinical Trial

Official title:

Accuracy of the CNAP™ Monitor (Continuous Non-invasive Arterial Pressure) Versus Invasive Radial Arterial Monitoring in Surgical Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01003665
• Other study ID #: CNAP-2009-1
• Status: Completed
• Phase: N/A
• First received: October 28, 2009
• Last updated: April 13, 2012
• Start date: February 2009
• Est. completion date: January 2012

Study information

• Verified date: April 2012
• Source: University of Schleswig-Holstein
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ministry of Health
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 195
• Est. completion date: January 2012
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Blood Pressure

Locations

Country	Name	City	State
Germany	Klinik für Anästhesiologie und Operative Intensivmedizin, Universitätsklinik Schleswig-Holstein, Campus Kiel	Kiel

Sponsors (1)

Lead Sponsor	Collaborator
University of Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bias and percentage error of CNAP compared with invasive arterial pressure measurement		1.) Induction of general anaesthesia. 2.) Maintanance of general anaesthesia. 3.) Intensive Care Treatement after surgery	No