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CompletedNCT02438228Updated Feb 11, 2016

Cardiac Output by Nine Different Pulse Contour Algorithms

An interventional study of Cardiac output measurement in Cardiac Output, sponsored by University Hospital Schleswig-Holstein. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-02-11.

Sponsored by University Hospital Schleswig-Holstein · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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).

Read the 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.

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Conditions studied

  • Cardiac Output

Keywords

  • cardiac output
  • transpulmonary thermodilution
  • pulse contour analysis
  • G09.330.380.124
03

In context

Lead sponsor

University Hospital Schleswig-Holstein is the lead sponsor of 157 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
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Study design

Phase
Not applicable
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Other
    Cardiac output measurement

    Other: Cardiac output measurement

Interventions

  • OtherCardiac 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.

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What researchers measure

Primary outcomes

  1. Accuracy of cardiac output in l/min by nine different pulse contour algorithms compared with transpulmonary thermodilution

    Time frame: After induction of anesthesia until the end of surgery

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Study locations

1 site
  • Berthold Bein
    Hamburg, 20099, Germany
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References and documents

Publications

  • 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. PubMed 24643474 ↗
  • 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. PubMed 20736431 ↗
  • 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. PubMed 23479677 ↗
  • 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. PubMed 24531685 ↗
  • 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. PubMed 25233178 ↗
  • Singer M. Oesophageal Doppler. Curr Opin Crit Care. 2009 Jun;15(3):244-8. doi: 10.1097/MCC.0b013e32832b7083. PubMed 19417642 ↗
  • 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. PubMed 28116294 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02438228
Lead sponsor
University Hospital Schleswig-Holstein
Responsible party
Ole Broch, MD (MD, University Hospital Schleswig-Holstein) — Principal investigator
First posted
May 8, 2015
Start date
Nov 2014
Primary completion
Nov 2015
Completion
Nov 2015
Last update
Feb 11, 2016

Study contacts

Berthold Bein, MD, PhD
principal investigator · Asklepios Klinik St. Georg

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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