Comparison of Continuous Non-invasive Arterial Pressure (CNAP) With Invasive Arterial Pressure Monitoring
This study has been completed.
Sponsor:
University of Schleswig-Holstein
Information provided by (Responsible Party):
Robert Hanss, University of Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT01003665
First received: October 28, 2009
Last updated: April 13, 2012
Last verified: April 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | October 28, 2009 | ||||||||
| Last Updated Date | April 13, 2012 | ||||||||
| Start Date ICMJE | February 2009 | ||||||||
| Primary Completion Date | May 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Bias and percentage error of CNAP compared with IBP [ Time Frame: perioperative ] [ Designated as safety issue: No ] | ||||||||
| Change History | Complete list of historical versions of study NCT01003665 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Comparison of Continuous Non-invasive Arterial Pressure (CNAP) With Invasive Arterial Pressure Monitoring | ||||||||
| Official Title ICMJE | Accuracy of the CNAP™ Monitor (Continuous Non-invasive Arterial Pressure) Versus Invasive Radial Arterial Monitoring in Surgical Patients | ||||||||
| 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:
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| 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. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | patients undergoing major surgery or intensive care unit treatement with the need for an invasive blood pressure measurement |
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| Condition ICMJE | Blood Pressure | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Intensive Care treatement
ASA status 3 or 4 patients with invasive blood pressure measurement on the intensive care unit |
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| Publications * | 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. Epub 2011 Dec 12. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 195 | ||||||||
| Completion Date | January 2012 | ||||||||
| Primary Completion Date | May 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Germany | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01003665 | ||||||||
| Other Study ID Numbers ICMJE | CNAP-2009-1 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Robert Hanss, University of Schleswig-Holstein | ||||||||
| Study Sponsor ICMJE | University of Schleswig-Holstein | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Schleswig-Holstein | ||||||||
| Verification Date | April 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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