Continuous and Non-invasive Measurements by Task Force® CORE/CARDIO in Autonomic Function Testing (AFT)

N/ANot Yet RecruitingNCT05977335

CNSystems Medizintechnik GmbH75 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Autonomic Dysfunction Orthostatic Intolerance

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Outcomes

Primary Outcomes

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.

Time frame: The agreement is calculated for the 5 minutes supine baseline period

Agreement of blood pressure between investigational and reference device.

Time frame: 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.

Time frame: The agreement is calculated for 90 seconds Deep Breathing period

Agreement of blood pressure between investigational and reference device.

Time frame: 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.