HD Sense Pilot Study - A Novel Method of Hemodynamic Monitoring

Study Overview
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Brief Summary
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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
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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)

Official Title
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A Novel Method of Hemodynamic Monitoring by Piezocapacitative Interlayer Sensor Technology - A Pilot Study

Conditions
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Hemodynamic Instability

Intervention / Treatment
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* Device: ConCardiac


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PIEZO-Group<br>All patients in this study receive IBP by PICCO and piezocapacitative-interlayer-technology measurement. | Device: ConCardiac<br>* All patients receive a piezocapacitative-interlayer-technology hemodynamic measurement by ConCardiac device (SectorCon GmbH, Berlin, Germany).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PPV | Percentual error of PPV < 30% for ConCardiac between ConCardiac and PICCO | Duration of surgery and perioperative care (an average of 24 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of surgery |  | Duration of surgery (an average of 4 hours) | 
| 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 | RR | perioperative (an average of 10 days) | 
| Vital signs of patients/heart frequency | HF | perioperative (an average of 10 days) | 
| Vital signs of patients/Cardiac index | CI | perioperative (an average of 10 days) | 
| Vital signs of patients/stroke volume | SV | perioperative (an average of 10 days) | 
| Vital signs of patients/pulse pressure variation | PPV | perioperative (an average of 10 days) | 
| Vital signs of patients/systemic vascular resistance index | SVRI | perioperative (an average of 10 days) | 
| Vital signs of patients/intrathoracic blood volume index | ITBV/I | perioperative (an average of 10 days) | 
| Vital signs of patients/extra vascular lung water index | ELWI | perioperative (an average of 10 days) | 
| Vital signs of patients/global enddiastolic volume index | GEDI | perioperative (an average of 10 days) | 
| Vital signs of patients/Ventilator settings | Ventilator settings | perioperative (an average of 10 days) | 
| Vital signs of patients/blood gases | BGA | perioperative (an average of 10 days) | 
| Vital signs of patients/creatinine | Creatinine | perioperative (an average of 10 days) | 
| Vital signs of patients/central venous oxygen saturation | ScvO2 | perioperative (an average of 10 days) | 
| Vital signs of patients/central venous pressure | CVP | perioperative (an average of 10 days) | 
| Vital signs of patients/diuresis | Diuresis | perioperative (an average of 10 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pulse contour analysis, capton, intraoperative monitoring