Comparison of a New Semi-invasive Monitoring System With Transpulmonary Thermodilution in Cardiac Surgery Patients

Cardiac Output, High Clinical Trial

Official title:

Estimation of Cardiac Output by a New Semi-invasive Monitoring System: Accuracy and Limitations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02312505
• Other study ID #: AZ 162/10
• Secondary ID: AZ 162/10
• Status: Completed
• Phase: N/A
• First received: December 3, 2012
• Last updated: October 24, 2016
• Start date: March 2012
• Est. completion date: December 2014

Study information

• Verified date: October 2016
• Source: University of Schleswig-Holstein
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cardiac Output, High

Intervention

Device:
• COPFX
cardiac Output by semi-invasive pulse contour analysis

Locations

Country	Name	City	State
Germany	Department of Anaesthesiology and Intensive Care Medicine	Kiel	Schleswig-Holstein

Sponsors (1)

Lead Sponsor	Collaborator
University of Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiac output by pulse contour Analysis compared with transpulmonary thermodilution	plotting cardiac output by a questionnaire, Statistics: correlation coefficients, Bland-Altman Analysis, trending ability by four Quadrant plots	participants will be followed for the start and the end of operation, on the average of 4 hours	Yes