Clinical trial NCT02312505: Comparison of a New Semi-invasive Monitoring System With Transpulmonary Thermodilution in Cardiac Surgery Patients
Official title: Estimation of Cardiac Output by a New Semi-invasive Monitoring System: Accuracy and Limitations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Output, High
Keywords: cardiac output monitoring
semi-invasive pulse contour analysis
transpulmonary thermodilution
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
First posted: 2014-12-09
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The aim of the study is to investigate the accuracy of a new semi-invasive cardiac output monitoring system in patients undergoing elective cardiac surgery. The investigators hypothesize that the semi-invasive device may be affected by mean arterial pressure and systemic vascular resistance.

Detailed description: A recently introduced semi-invasive monitoring system consists of an algorithm that provides beat-to-beat measurement of CI by analysis of the arterial blood pressure tracing. By using the autocalibration mode this software calculates the individual aortic compliance and systemic vascular resistance by taking patient data like age, height, weight and gender into account. After estimation of beat-to-beat stroke volume, a subsequent multiplication by the heart rate delivers pulse contour cardiac index. Furthermore, this device offers the opportunity for external calibration by a reference technique, e.g. pulmonary or transpulmonary thermodilution.

The aim of the present study was to investigate the accuracy and trending ability of autocalibrated semi-invasive CI by a new arterial waveform analysis compared with transpulmonary thermodilution before and after cardiopulmonary bypass (CPB).

Eligibility criteria: Inclusion Criteria:

Patients undergoing elective coronary artery bypass grafting Personal declaration of consent to the study

Exclusion Criteria:

Patients \<18 years of age A left ventricular ejection fraction ≤0.5 Emergency procedures Patients with haemodynamic instability requiring continuous pharmacologic support Patients with intracardiac shunts Severe aortic-, tricuspid- or mitral stenosis or insufficiency Mechanical circulatory support.

Primary outcomes:
measure: cardiac output by pulse contour Analysis compared with transpulmonary thermodilution
timeFrame: participants will be followed for the start and the end of operation, on the average of 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: Department of Anaesthesiology and Intensive Care Medicine
state: Schleswig-Holstein
Study officials:
affiliation: University Schleswig-Holstein, Campus Kiel, Germany
name: Berthold Bein, Professor
role: STUDY_DIRECTOR
References:
citation: Broch O, Carbonell J, Ferrando C, Metzner M, Carstens A, Albrecht M, Gruenewald M, Hocker J, Soro M, Steinfath M, Renner J, Bein B. Accuracy of an autocalibrated pulse contour analysis in cardiac surgery patients: a bi-center clinical trial. BMC Anesthesiol. 2015 Nov 26;15:171. doi: 10.1186/s12871-015-0153-2.