Blood Pressure Monitoring
Conditions
Interventions
Group 1: Measurements will be performed during neurosurgical procedures with continuous comparisons made against invasive reference measurements (i.e. arterial catheter).
Sponsors
Klinik und Poliklinik für Anästhesiologie, Zentrum für Anästhesiologie und Intensivmedizin, Universitätsklinikum Hamburg-Eppendorf
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients scheduled for elective surgery who require invasive BP monitoring with an intra-arterial catheter placed in the A. radialis for clinical indications unrelated to the study Adult patients (patients aged = 18 years)
Exclusion criteria
Exclusion criteria: Patients with pronounced edema in the hands Patients with vascular implants at the sites of non-invasive BP measurement (fingers and upper arms, respectively) Patients with pronounced disturbance of peripheral blood circulation (peripheral artery disease of Fontaine state II and above, Raynaud syndrome, a-v-shunt etc.) Patients with tonic seizures and/or excessive movements Patients with history of arrhythmias Patients with arteriosclerosis Patients with atrial fibrillation Patients with valvular disease of grade 2 or above Patients with cardiac assist devices Patients who, in addition to invasive BP monitoring, require NIBP measurements unrelated to the investigational devices Patients who obtain vasoactive medications on the same arm as used for upper-arm NIBP measurements from the NiCCI System 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 > 10mmHg in systolic or diastolic BP during assessment of lateral differences Capillary refill-time > 2 seconds
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the agreement between the non-invasive blood pressure measurement of the NiCCI system and the invasive reference (systolic, diastolic and mean arterial pressure readings on a beat-by-beat basis or on the basis of several values/sec). Descriptive statistics, scatterplot, Bland-Altman and correlation analysis will be performed. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoint is the agreement between the non-invasive blood pressure measurement of the CNAP system and the invasive reference (systolic, diastolic and mean arterial pressure readings on a beat-by-beat basis or on the basis of several values/sec). Descriptive statistics, scatterplot, Bland-Altman and correlation analysis will be performed. | — |
Countries
Germany
Contacts
Public ContactMoritz Flick
Klinik und Poliklinik für Anästhesiologie, Zentrum für Anästhesiologie und Intensivmedizin, Universitätsklinikum Hamburg-Eppendorf
Outcome results
None listed