Hemodynamic Instability
Conditions
Keywords
pulse contour analysis, capton, intraoperative monitoring
Brief summary
Measurement of arterial blood pressure is a basic monitoring in the perioperative setting. It is a standard monitoring to assure an adequate cerebral perfusion pressure and is a basic parameter of hemodynamic optimization. Until now standard methods for blood pressure measurement are non-invasive interval monitoring by arm cuff (Riva-Rocci) or direct, continuous and invasive by inserting an intraarterial catheter. This observational study will show, that a new non-invasive piezocapacitative-interlayer technology will make continuous blood pressure monitoring and non-invasive pulse contour analysis available.
Detailed description
Measurement of arterial blood pressure is a basic monitoring in the perioperative setting. It is a standard monitoring to assure an adequate cerebral perfusion pressure and is a basic parameter of hemodynamic optimization. Until now standard methods for blood pressure measurement are non-invasive interval monitoring by arm cuff (Riva-Rocci) or direct, continuous and invasive by inserting an intraarterial catheter. This observational study will show, that a new non-invasive piezocapacitative-interlayer technology will make continuous blood pressure monitoring and non-invasive pulse contour analysis available. For this reason all patients will get a basic monitoring (NIBP, ECG, SpO2)
Interventions
DEVICEConCardiac
All patients receive a piezocapacitative-interlayer-technology hemodynamic measurement by ConCardiac device (SectorCon GmbH, Berlin, Germany).
Sponsors
Charite University, Berlin, Germany
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* elective surgery and general anesthesia * age \>/= 18 years * any surgery in ENT/trauma/gynecology/visceral surgery/thoracic surgery/urology/neuro surgery/cardio surgery (N=10) * cardio surgery (N=10) * Transcatheter Aortic Valve Implantation (N=20) * cystectomy (N=10) * neurosurgery with an expected postoperative ICU stay \>/= 20 hours (N=10)
Exclusion criteria
* pregnant or breastfeeding patients * emergency surgery * participation in a clinical interventional study * BMI \>35 kg/m² * impossibility to place the ConCardiac interlayer * difference of blood pressure of right and left arm \> 12 mmHg * pAVK Fontaine IV * arrythmia absoluta * vitium cordis \>/=3 * ejection fraction \<35% * TAPSE \</=16mm * need of IABP
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PPV | Duration of surgery and perioperative care (an average of 24 hours) | Percentual error of PPV \< 30% for ConCardiac between ConCardiac and PICCO |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of anesthesia | Duration of surgery (an average of 4 hours) | — |
| intraoperative blood loss | Duration of surgery and perioperative care (an average of 24 hours) | — |
| Duration of mechanical ventilation | Duration of surgery (an average of 4 hours) | — |
| Duration of renal replacement therapy | perioperative (an average of 10 days) | — |
| Length of hospital stay | perioperative (an average of 10 days) | — |
| Blood products and volume needed perioperative | perioperative (an average of 10 days) | — |
| ICU scores (TISS) | perioperative (an average of 10 days) | — |
| ICU scores (SOFA) | perioperative (an average of 10 days) | — |
| ICU scores (SAPS) | perioperative (an average of 10 days) | — |
| Incidence of organ failure or complications | perioperative (an average of 10 days) | — |
| Vital signs of patients/blood pressure | perioperative (an average of 10 days) | RR |
| Vital signs of patients/heart frequency | perioperative (an average of 10 days) | HF |
| Duration of surgery | Duration of surgery (an average of 4 hours) | — |
| Vital signs of patients/stroke volume | perioperative (an average of 10 days) | SV |
| Vital signs of patients/pulse pressure variation | perioperative (an average of 10 days) | PPV |
| Vital signs of patients/systemic vascular resistance index | perioperative (an average of 10 days) | SVRI |
| Vital signs of patients/intrathoracic blood volume index | perioperative (an average of 10 days) | ITBV/I |
| Vital signs of patients/extra vascular lung water index | perioperative (an average of 10 days) | ELWI |
| Vital signs of patients/global enddiastolic volume index | perioperative (an average of 10 days) | GEDI |
| Vital signs of patients/Ventilator settings | perioperative (an average of 10 days) | Ventilator settings |
| Vital signs of patients/blood gases | perioperative (an average of 10 days) | BGA |
| Vital signs of patients/creatinine | perioperative (an average of 10 days) | Creatinine |
| Vital signs of patients/central venous oxygen saturation | perioperative (an average of 10 days) | ScvO2 |
| Vital signs of patients/central venous pressure | perioperative (an average of 10 days) | CVP |
| Vital signs of patients/diuresis | perioperative (an average of 10 days) | Diuresis |
| Vital signs of patients/Cardiac index | perioperative (an average of 10 days) | CI |
Countries
Germany
Outcome results
None listed