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Clinical Trials/NCT01003665
NCT01003665
Completed
Not Applicable

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

University Hospital Schleswig-Holstein1 site in 1 country195 target enrollmentFebruary 2009
ConditionsBlood Pressure

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Blood Pressure
Sponsor
University Hospital Schleswig-Holstein
Enrollment
195
Locations
1
Primary Endpoint
Bias and percentage error of CNAP compared with invasive arterial pressure measurement
Status
Completed
Last Updated
14 years ago

Overview

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

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.

Registry
clinicaltrials.gov
Start Date
February 2009
End Date
January 2012
Last Updated
14 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital Schleswig-Holstein
Responsible Party
Principal Investigator
Principal Investigator

Robert Hanss

Prof. Dr. Robert Hanss

University Hospital Schleswig-Holstein

Eligibility Criteria

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

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

Study Sites (1)

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