Non-invasive Cardiac Output Monitoring (esCCO™) in Critically Ill Patients Within ICU

Study Overview
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Brief Summary
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Evaluation of a non-invasive technique to measure cardiac output (esCCO™) with the clinical goldstandard of the transcardiopulmonal thermodilution technique (PiCCO®). Effect of different potential interference factors to the accuracy of measurement (changing concentration of norepinephrine, generally severity of the basic disease - APACHE II score).

Detailed Description
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The measurements have to estimate the agreement of esCCO™ and PiCCO® related to the cardiac output (cardiac index). It should consult a comparison of methods between a complete non-invasive cardiac output monitoring method (esCCO™) and the transcardiopulmonal thermodilution technique (PiCCO®). The accuracy shall carve out as well as the power of agreement of both measurement methods. It takes two simultaneous measurements at a time of critically ill patients at interdisciplinary surgical intensive care units. Furthermore the force of the major variables (1. requirement of norepinephrine and 2. APACHE II-score) to the estimators shall be realized. esCCO™ vs. (PiCCO®) This research shall include 100 patients which have to undergo a complex intensive care treatment within predefined therapy intentions. During a daily screening within the interdisciplinary surgical intensive care units of the Universitätsklinikum Schleswig-Holstein, Campus Kiel it will be opted for the inclusion of the patients. Points of time x [x ε M and M = {1, 2, 3, 4}] - two test series (measurement 1 and 2). According to the ability of the patient to the research the predefined point of time number 1 will be supposed (point of time number 1: inclusion criterium). The predefined point of time number 2 will be supposed if the therapy concept is planned or changed. The point of time number 3 is defined as the re-evaluation in the course of changed therapy conceptions. If the medical practitioner team decides to renounce the PiCCO-system, the predefined point of time number 4 has arrived. The requirement of norepinephrine will be registered in every measurement (1 and 2). The APACHE II-score will be surveyed each point of time x (see above). The remaining treatment of the patients will be performed in the conventional way by the medical practitioner team within the interdisciplinary surgical intensive care units.

Official Title
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Cardiac Output Monitoring System (esCCO™) in Comparison to Transcardiopulmonal Thermodilution Technique (PiCCO®) in Critically Ill Patients Within Interdisciplinary Surgical Intensive Care Units

Conditions
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Cardiac Output

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The extended haemodynamic monitoring procedure PiCCO® has already been established due to the clinical decision making of the medical practitioner team Exclusion Criteria: atrial fibrillation cardiac arrhythmias cardiac pacemaker intraaortic counterpulsation pericardial tamponade age < 18 years missing or incorrect patient consent form

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| requirement of norepinephrine<br>requirement of norepinephrine <0,1 µg/kgKG/min versus ≥0,1 µg/kgKG/min | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison between esCCOTM and the transcardiopulmonal thermodilution technique (PiCCO®) | Comparison of cardiac output, utilizing cardiac index (CI), between (esCCO™) and the clinical goldstandard of the transcardiopulmonal thermodilution technique (PiCCO®) | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of different potential interference factors to the accuracy of measurement (changing concentration of norepinephrine, generally severity of the basic disease) | Comparison of cardiac output, utilizing cardiac index (CI), between (esCCO™) and the clinical goldstandard of the transcardiopulmonal thermodilution technique (PiCCO®) | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac Index, Noninvasive, esCCO, PiCCO, Thermodilution