Continuous and Non-invasive Measurements by Task Force® CORE/CARDIO in Autonomic Function Testing (AFT)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 75
- 主要终点
- Agreement of blood pressure between investigational and reference device.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (patients aged ≥ 18 years)
- •Patients giving written informed consent to participate in the study.
- •Patients with intact perfusion of both hands evidenced by a positive Allen's test.
- •Patients with orthostatic intolerance will be included
排除标准
- •Patients with vascular implants at the sites of non-invasive BP measurement (fingers or upper arms)
- •Very low perfusion in the periphery
- •Arterial vascular diseases (arteriosclerosis, Raynaud's syndrome, endarteritis obliterans, collagenosis, severely advanced vascular diseases (PAOD))
- •Patients with significant edema in the fingers
- •Patients with atrial fibrillation
- •Patients with valvular disease of grade 2 or above
- •Patients with ventricular assist devices
- •Subjects not passing the Allen's test for both hands.
- •Patients with a large lateral difference in BP (> 15 mmHg for systolic BP and/or >10 mmHg for diastolic BP) or with same arm measurement differences > 10 mmHg in systolic or diastolic BP during assessment of lateral differences
研究组 & 干预措施
Orthostatic Intolerance Patients
干预措施: Autonomic Function Testing (Diagnostic Test)
结局指标
主要结局
Agreement of blood pressure between investigational and reference device.
时间窗: The agreement is calculated for 10 minutes head-up tilt table test period
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.
Agreement of heart rate between investigational and reference device.
时间窗: The agreement is calculated for 10 minutes head-up tilt table test period
The agreement of heart rate (bpm \[beats per minute)\] between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.
Agreement of cardiac output between investigational and reference device.
时间窗: The agreement is calculated for 10 minutes head-up tilt table test period
The agreement of cardiac output (in l/min) between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.
Agreement of blood pressure between investigational and reference device.
时间窗: The agreement is calculated for the 5 minutes supine baseline period
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.
Agreement of blood pressure between investigational and reference device.
时间窗: The agreement is calculated for 60 seconds: during (15 seconds) plus after (45 seconds) valsava maneuver
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.
Agreement of blood pressure between investigational and reference device.
时间窗: The agreement is calculated for 90 seconds Deep Breathing period
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.
Agreement of heart rate between investigational and reference device.
时间窗: The agreement is calculated for the 5 minutes supine baseline period
The agreement of heart rate (bpm \[beats per minute)\] between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.
Agreement of heart rate between investigational and reference device.
时间窗: The agreement is calculated for 60 seconds: during (15 seconds) plus after (45 seconds) valsava maneuver
The agreement of heart rate (bpm \[beats per minute)\] between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.
Agreement of heart rate between investigational and reference device.
时间窗: The agreement is calculated for 90 seconds Deep Breathing period
The agreement of heart rate (bpm \[beats per minute)\] between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.
Agreement of cardiac output between investigational and reference device.
时间窗: The agreement is calculated for the 5 minutes supine baseline period
The agreement of cardiac output (in l/min) between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.
Agreement of cardiac output between investigational and reference device.
时间窗: The agreement is calculated for 60 seconds: during (15 seconds) plus after (45 seconds) valsava maneuver
The agreement of cardiac output (in l/min) between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.
Agreement of cardiac output between investigational and reference device.
时间窗: The agreement is calculated for 90 seconds Deep Breathing period
The agreement of cardiac output (in l/min) between both devices will be assessed by means of Scatterplot and Bland-Altman analysis.
次要结局
未报告次要终点