Continuous and Non-invasive Measurements by Task Force® CORE/CARDIO in Autonomic Function Testing (AFT)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCNSystems Medizintechnik GmbH
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Autonomic Function Testing
Diagnostic testAutonomic Function Testing (AFT) includes Valsalva Manoever, Deep Breathing Test, and Head-up Tilt Table Testing.
Treatment groups
75 Participants
are divided into 1 treatment groupGroup A: Orthostatic Intolerance Patients1 intervention
Trial outcomes
Primary outcomes
1
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 period2
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 60 seconds: during (15 seconds) plus after (45 seconds) valsava maneuver3
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 90 seconds Deep Breathing period4
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 10 minutes head-up tilt table test periodLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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