Comparison of Continuous Non-invasive Arterial Pressure (CNAP) With Invasive Arterial Pressure Monitoring
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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 during:
- induction and maintenance of general anaesthesia
- intensive care unit treatment of postoperative patients with an ASA 3 or 4 status
| 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 |
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 195 |
| Study Start Date: | February 2009 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Intensive Care treatement
ASA status 3 or 4 patients with invasive blood pressure measurement on the intensive care unit
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
patients undergoing major surgery or intensive care unit treatement with the need for an invasive blood pressure measurement
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
Contacts and Locations| Germany | |
| Klinik für Anästhesiologie und Operative Intensivmedizin, Universitätsklinik Schleswig-Holstein, Campus Kiel | |
| Kiel, Germany, 24106 | |
| Study Chair: | Markus Steinfath, Professor | Klinik für Anästhesiologie und Operative Intensivmedizin, UKSH Kiel |
| Study Director: | Robert Hanss, Professor | Klinik für Anästhesiologie und Operative Intensivmedizin, UKSH Kiel |
More Information
Publications:
| Responsible Party: | Robert Hanss, Prof. Dr. Robert Hanss, University of Schleswig-Holstein |
| ClinicalTrials.gov Identifier: | NCT01003665 History of Changes |
| Other Study ID Numbers: | CNAP-2009-1 |
| Study First Received: | October 28, 2009 |
| Last Updated: | April 13, 2012 |
| Health Authority: | Germany: Ministry of Health |
ClinicalTrials.gov processed this record on June 18, 2013