Cardiac Output by Nine Different Pulse Contour Algorithms

Cardiac Output Clinical Trial

Official title:

Estimation of Cardiac Output by Nine Different Pulse Contour Algorithms Compared With Transpulmonary Thermodilution

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02438228
• Other study ID #: AZ-138
• Status: Completed
• Phase: N/A
• First received: April 29, 2015
• Last updated: February 10, 2016
• Start date: November 2014
• Est. completion date: November 2015

Study information

• Verified date: February 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 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cardiac Output

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Germany	Berthold Bein	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
University of Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

References & Publications (6)

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. Review. — View Citation

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. — View Citation

Schlöglhofer 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. Review. — View Citation

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

Smetkin AA, Hussain A, Kuzkov VV, Bjertnæs 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of cardiac output in l/min by nine different pulse contour algorithms compared with transpulmonary thermodilution		After induction of anesthesia until the end of surgery	Yes