Prospective, single-center, open clinical trial to compare two non-calibrated systems for the continuous measurement of cardiac output and stroke volume variation (LiDCO rapid®, ICON®) with a calibrated system using Thermodilutionin (PiCCO®) in adult cardiac surgical patients.

Not Applicable

• Conditions: Diseases that make a determination of cardiac output and stroke volume variation necessary; I97; Postprocedural disorders of circulatory system, not elsewhere classified

• Registration Number: DRKS00005582
• Lead Sponsor: Klinik für Anästhesiologie, operative Intensivmedizin und SchmerztherapieHelios Klinikum Krefeld

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-14
• Study Completion: 2015-11-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Planned determination of cardiac output (CO) and stroke volume variation (SVV) by a monitoring procedure in adult cardiac surgical patients.
• Written consent of the patient.

Exclusion Criteria

• Absolute arrhythmia.
• Spontaneous breathing.
• ASA> 4
• infections or skin diseases in the area of possible puncture sites.
• Participation in another interventional clinical trials.
• diseases or disorders that makes the participation in this clinical trial not possible in the opinion of the investigator (support systems in operation (IABP, MECC), hemodynamic instability, catecholamine therapy).

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity obtained with the LiDCO rapid®, the PiCCO® and the ICON® apparatus parameters stroke volume variation (SVV) and pulse pressure variation (PPV) (excluding LiDCO rapid®) for the prediction of fluid responsiveness (change in cardiac output by = 10% by volume rendering) at different tidal volume (validation SVV, PPV)

Secondary Outcome Measures

Name	Time	Method
• Sensitivity and specificity of the clinical Passive Leg Raising test to predict fluid responsiveness (same direction changes of cardiac output by = 10% after PLRT and volume administration) at different tidal volume (validation PLRT).<br>• difference between the LiDCO rapid® and the ICON® determined hemodynamic parameters cardiac output (CO), stroke volume variation (SVV) and pulse pressure variation (PPV) (excluding LiDCO rapid®) and measured by PiCCO® values ??(validation LiDCO rapid® and ICON® vs. PiCCO®) calibrated taking into account the repetition accuracy of PiCCO® measurement method (PiCCO® vs. PiCCO® not calibrated) at different tidal volumes.<br>• extent and direction of changes in the cardiac output associated with the highest sensitivity and specificity to changes in the parameters of fluid responsiveness (SVV, PPV).