Non-invasive Cardiac Output Monitoring (esCCO™) in Critically Ill Patients Within ICU
- Conditions
- Cardiac Output
- Registration Number
- NCT02682615
- Lead Sponsor
- University Hospital Schleswig-Holstein
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- The extended haemodynamic monitoring procedure PiCCO® has already been established due to the clinical decision making of the medical practitioner team
- atrial fibrillation
- cardiac arrhythmias
- cardiac pacemaker
- intraaortic counterpulsation
- pericardial tamponade
- age < 18 years
- missing or incorrect patient consent form
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison between esCCOTM and the transcardiopulmonal thermodilution technique (PiCCO®) through study completion, an average of 1 year Comparison of cardiac output, utilizing cardiac index (CI), between (esCCO™) and the "clinical goldstandard" of the transcardiopulmonal thermodilution technique (PiCCO®)
- Secondary Outcome Measures
Name Time Method Effect of different potential interference factors to the accuracy of measurement (changing concentration of norepinephrine, generally severity of the basic disease) through study completion, an average of 1 year Comparison of cardiac output, utilizing cardiac index (CI), between (esCCO™) and the "clinical goldstandard" of the transcardiopulmonal thermodilution technique (PiCCO®)
Trial Locations
- Locations (1)
GERMANY - Universitätsklinikum Schleswig-Holstein
🇩🇪Kiel, Schleswig-Holstein, Germany