Clinical trial NCT01003665: Comparison of Continuous Non-invasive Arterial Pressure (CNAP) With Invasive Arterial Pressure Monitoring
Official title: Accuracy of the CNAP™ Monitor (Continuous Non-invasive Arterial Pressure) Versus Invasive Radial Arterial Monitoring in Surgical Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Pressure
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
First posted: 2009-10-29
Enrollment: 195
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients undergoing major surgery or intensive care unit treatement with the need for an invasive blood pressure measurement

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.

Eligibility criteria: 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

Primary outcomes:
measure: Bias and percentage error of CNAP compared with invasive arterial pressure measurement
timeFrame: 1.) Induction of general anaesthesia. 2.) Maintanance of general anaesthesia. 3.) Intensive Care Treatement after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: Klinik für Anästhesiologie und Operative Intensivmedizin, Universitätsklinik Schleswig-Holstein, Campus Kiel
Study officials:
affiliation: Klinik für Anästhesiologie und Operative Intensivmedizin, UKSH Kiel
name: Markus Steinfath, Professor
role: STUDY_CHAIR
affiliation: Klinik für Anästhesiologie und Operative Intensivmedizin, UKSH Kiel
name: Robert Hanss, Professor
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1093/bja/aer394. Epub 2011 Dec 12.
citation: Ilies C, Grudev G, Hedderich J, Renner J, Steinfath M, Bein B, Haake N, Hanss R. Comparison of a continuous noninvasive arterial pressure device with invasive measurements in cardiovascular postsurgical intensive care patients: a prospective observational study. Eur J Anaesthesiol. 2015 Jan;32(1):20-8. doi: 10.1097/EJA.0000000000000136.