Cardiac Output by Nine Different Pulse Contour Algorithms

NCT ID: NCT02438228

Last Updated: 2016-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2015-11-30

Brief Summary

The aim of the present study is to compare accuracy and precision of Cardiac Output (CO) by nine different pulse contour algorithms with transpulmonary thermodilution before and after cardiopulmonary bypass (CPB).

Detailed Description

After induction of anesthesia, a central venous catheter and a transpulmonary thermodilution catheter (Pulsion Medical Systems, Munich, Germany) are introduced in the right internal jugular vein and in the femoral artery, respectively. The thermodilution catheter is connected to a PiCCO2 monitor (Software version 1.3.0.8). Thereafter, placement of an esophageal doppler probe is performed and the probe is connected to a unique Monitoring System (Deltex Medical, Chichester, UK) with nine different pulse contour algorithms. Cardiac Output by esophageal doppler is used to calibrate the nine different pulse contour algorithms.

After induction of anesthesia and establishment of all monitoring devices, a passive leg raising maneouvre (PLR) is performed and hemodynamic variables including CO by transpulmonary thermodilution (COTPTD) and CO by nine different pulse contour algorithms (COX1-9) are recorded before, during and after PLR. Subsequently, measurements of COTPTD and COX1-9 are carried out every 10 minutes until the beginning of CPB. Fifteen minutes after weaning from cardiopulmonary bypass calibration of nine different pulse contour algorithms by esophageal doppler are performed again and measurements of CITPTD and CIPFX are restarted up to the end of the surgical Intervention.

Conditions

Cardiac Output

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Cardiac output measurement

Group Type: OTHER

Cardiac output measurement

Intervention Type: OTHER

Measurement of cardiac output by transpulmonary thermodilution, nine different pulse contour algorithms and esophageal doppler before, during and after a PLR-maneouvre and every 10 minutes before and after cardiopulmonary Bypass.

Interventions

Cardiac output measurement

Measurement of cardiac output by transpulmonary thermodilution, nine different pulse contour algorithms and esophageal doppler before, during and after a PLR-maneouvre and every 10 minutes before and after cardiopulmonary Bypass.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients > 18 years of age with a left ventricular ejection fraction ≥ 0.5.
• Patients undergoing coronary artery bypass grafting.

Exclusion Criteria

• Patients <18 years of age and with a left ventricular ejection fraction ≤0.5 are not considered for the study.
• Emergency procedures and patients with hemodynamic instability requiring continuous pharmacologic support, intracardiac shunts, severe aortic-, tricuspid- or mitral stenosis or insufficiency and mechanical circulatory support were also excluded.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Schleswig-Holstein

OTHER

Sponsor Role: lead

Responsible Party

Ole Broch, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Berthold Bein, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Asklepios Klinik St. Georg

Locations

Berthold Bein

Hamburg, City state of Hamburg, Germany

Countries

Germany

References

Schloglhofer T, Gilly H, Schima H. Semi-invasive measurement of cardiac output based on pulse contour: a review and analysis. Can J Anaesth. 2014 May;61(5):452-79. doi: 10.1007/s12630-014-0135-8. Epub 2014 Mar 19.

Reference Type: BACKGROUND

PMID: 24643474 (View on PubMed)

Critchley LA, Lee A, Ho AM. A critical review of the ability of continuous cardiac output monitors to measure trends in cardiac output. Anesth Analg. 2010 Nov;111(5):1180-92. doi: 10.1213/ANE.0b013e3181f08a5b. Epub 2010 Aug 24.

Reference Type: BACKGROUND

PMID: 20736431 (View on PubMed)

Suehiro K, Tanaka K, Funao T, Matsuura T, Mori T, Nishikawa K. Systemic vascular resistance has an impact on the reliability of the Vigileo-FloTrac system in measuring cardiac output and tracking cardiac output changes. Br J Anaesth. 2013 Aug;111(2):170-7. doi: 10.1093/bja/aet022. Epub 2013 Mar 10.

Reference Type: BACKGROUND

PMID: 23479677 (View on PubMed)

Smetkin AA, Hussain A, Kuzkov VV, Bjertnaes LJ, Kirov MY. Validation of cardiac output monitoring based on uncalibrated pulse contour analysis vs transpulmonary thermodilution during off-pump coronary artery bypass grafting. Br J Anaesth. 2014 Jun;112(6):1024-31. doi: 10.1093/bja/aet489. Epub 2014 Feb 13.

Reference Type: BACKGROUND

PMID: 24531685 (View on PubMed)

Huang L, Critchley LA. An assessment of two Doppler-based monitors to track cardiac output changes in anaesthetised patients undergoing major surgery. Anaesth Intensive Care. 2014 Sep;42(5):631-9. doi: 10.1177/0310057X1404200514.

Reference Type: BACKGROUND

PMID: 25233178 (View on PubMed)

Singer M. Oesophageal Doppler. Curr Opin Crit Care. 2009 Jun;15(3):244-8. doi: 10.1097/MCC.0b013e32832b7083.

Reference Type: BACKGROUND

PMID: 19417642 (View on PubMed)

Broch O, Bein B, Gruenewald M, Masing S, Huenges K, Haneya A, Steinfath M, Renner J. Accuracy of Cardiac Output by Nine Different Pulse Contour Algorithms in Cardiac Surgery Patients: A Comparison with Transpulmonary Thermodilution. Biomed Res Int. 2016;2016:3468015. doi: 10.1155/2016/3468015. Epub 2016 Dec 28.

Reference Type: DERIVED

PMID: 28116294 (View on PubMed)

Other Identifiers

AZ-138

Identifier Type: -

Identifier Source: org_study_id