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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01003665

Enrollment

195

Registered

2009-10-29

Start date

2009-02-28

Completion date

2012-01-31

Last updated

2012-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Countries

Germany

Outcome results