Background: The investigational device, "Task ForceĀ® CORE" (TFC, CNSystems Medizintechnik GmbH, Graz, Austria) together with the "Task ForceĀ® CARDIO" (TFCARDIO, CNSystems Medizintechnik GmbH, Graz, Austria) medical device software, is a new CE-marked medical device for continuous non-invasive determination of blood pressure (BP), cardiac output (CO) and derived parameters based on the well established CNAPĀ® (continuous non-invasive arterial pressure) technology by CNSystems. Aim: The primary aim of this prospective, method comparison, open study is data acquisition for the performance evaluation of the TFC during autonomic function testing in comparison with an clinically accepted reference method. Setting: The setting of the clinical investigation will be the autonomic function testing laboratory at the Department of Neurology, the University Hospital Center Zagreb. Inclusion criteria: Patients who are over 18 years and who provide written informed consent. Sample size: The study has an calculated sample size of 70 patients. Considering a drop-out rate of 5%, a total of 75 patients will be included. Statistics: Descriptive statistics, values for the percentage error and correlation estimates will be derived. Furthermore, scatterplot, Bland-Altman analysis, concordance analysis of parameter changes and further comparative statistics will be performed.
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Agreement of blood pressure between investigational and reference device.
Timeframe: The agreement is calculated for the 5 minutes supine baseline period
Agreement of blood pressure between investigational and reference device.
Timeframe: The agreement is calculated for 60 seconds: during (15 seconds) plus after (45 seconds) valsava maneuver
Agreement of blood pressure between investigational and reference device.
Timeframe: The agreement is calculated for 90 seconds Deep Breathing period
Agreement of blood pressure between investigational and reference device.
Timeframe: The agreement is calculated for 10 minutes head-up tilt table test period
Agreement of heart rate between investigational and reference device.
Timeframe: The agreement is calculated for the 5 minutes supine baseline period
Agreement of heart rate between investigational and reference device.
Timeframe: The agreement is calculated for 60 seconds: during (15 seconds) plus after (45 seconds) valsava maneuver
Agreement of heart rate between investigational and reference device.
Timeframe: The agreement is calculated for 90 seconds Deep Breathing period
Agreement of heart rate between investigational and reference device.
Timeframe: The agreement is calculated for 10 minutes head-up tilt table test period
Agreement of cardiac output between investigational and reference device.
Timeframe: The agreement is calculated for the 5 minutes supine baseline period
Agreement of cardiac output between investigational and reference device.
Timeframe: The agreement is calculated for 60 seconds: during (15 seconds) plus after (45 seconds) valsava maneuver
Agreement of cardiac output between investigational and reference device.
Timeframe: The agreement is calculated for 90 seconds Deep Breathing period
Agreement of cardiac output between investigational and reference device.
Timeframe: The agreement is calculated for 10 minutes head-up tilt table test period