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Background: The investigational device, "Task Force® CORE" (TFC, CNSystems Medizintechnik GmbH, Graz, Austria) together with the "Task Force® 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 CNAP® (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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orthostatic Intolerance Patients |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autonomic Function Testing | Diagnostic Test | Autonomic Function Testing (AFT) includes Valsalva Manoever, Deep Breathing Test, and Head-up Tilt Table Testing. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Agreement of blood pressure between investigational and reference device. | The agreement of blood pressure variables [systolic, diastolic and mean pressure in mmHg [millimetres of mercury)] between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.](streamdown:incomplete-link) | The agreement is calculated for the 5 minutes supine baseline period |
| Agreement of blood pressure between investigational and reference device. | The agreement of blood pressure variables [systolic, diastolic and mean pressure in mmHg [millimetres of mercury)] between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.](streamdown:incomplete-link) | 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. | The agreement of blood pressure variables [systolic, diastolic and mean pressure in mmHg [millimetres of mercury)] between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.](streamdown:incomplete-link) | The agreement is calculated for 90 seconds Deep Breathing period |
| Agreement of blood pressure between investigational and reference device. | The agreement of blood pressure variables [systolic, diastolic and mean pressure in mmHg [millimetres of mercury)] between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.](streamdown:incomplete-link) | The agreement is calculated for 10 minutes head-up tilt table test period |
| Agreement of heart rate between investigational and reference device. | The agreement of heart rate (bpm [beats per minute)] between both devices will be assessed by means of Scatterplot and Bland-Altman analysis. | The agreement is calculated for the 5 minutes supine baseline period |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who present at the Referral Center for Autonomic Nervous System of the University Hospital Center Zagreb referred to autonomous nervous system testing will be included.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chief Technology Officer | Contact | 00433167234560 | office@cnsystems.com |
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| ID | Term |
|---|---|
| D054969 | Primary Dysautonomias |
| D054971 | Orthostatic Intolerance |
| ID | Term |
|---|---|
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| Agreement of heart rate between investigational and reference device. | The agreement of heart rate (bpm [beats per minute)] between both devices will be assessed by means of Scatterplot and Bland-Altman analysis. | 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. | The agreement of heart rate (bpm [beats per minute)] between both devices will be assessed by means of Scatterplot and Bland-Altman analysis. | The agreement is calculated for 90 seconds Deep Breathing period |
| Agreement of heart rate between investigational and reference device. | The agreement of heart rate (bpm [beats per minute)] between both devices will be assessed by means of Scatterplot and Bland-Altman analysis. | The agreement is calculated for 10 minutes head-up tilt table test period |
| Agreement of cardiac output between investigational and reference device. | The agreement of cardiac output (in l/min) between both devices will be assessed by means of Scatterplot and Bland-Altman analysis. | The agreement is calculated for the 5 minutes supine baseline period |
| Agreement of cardiac output between investigational and reference device. | The agreement of cardiac output (in l/min) between both devices will be assessed by means of Scatterplot and Bland-Altman analysis. | 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. | The agreement of cardiac output (in l/min) between both devices will be assessed by means of Scatterplot and Bland-Altman analysis. | The agreement is calculated for 90 seconds Deep Breathing period |
| Agreement of cardiac output between investigational and reference device. | The agreement of cardiac output (in l/min) between both devices will be assessed by means of Scatterplot and Bland-Altman analysis. | The agreement is calculated for 10 minutes head-up tilt table test period |
| D013568 | Pathological Conditions, Signs and Symptoms |