NCT02438228

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 8, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

February 11, 2016

Status Verified

February 1, 2016

Enrollment Period

1 year

First QC Date

April 29, 2015

Last Update Submit

February 10, 2016

Conditions

Cardiac Output

Keywords

cardiac outputtranspulmonary thermodilutionpulse contour analysisG09.330.380.124

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Cardiac output measurement

OTHER
Other: Cardiac output measurement

Interventions

Cardiac output measurementOTHER

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.

Cardiac output measurement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Berthold Bein

Hamburg, Hamburg, 20099, Germany

Location

Related Publications (7)

  • 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.

    PMID: 24643474BACKGROUND

  • 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.

    PMID: 20736431BACKGROUND

  • 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.

    PMID: 23479677BACKGROUND

  • 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.

    PMID: 24531685BACKGROUND

  • 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.

    PMID: 25233178BACKGROUND

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

    PMID: 19417642BACKGROUND

  • 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.

    PMID: 28116294DERIVED

Study Officials

  • Berthold Bein, MD, PhD

    Asklepios Klinik St. Georg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 29, 2015

First Posted

May 8, 2015

Study Start

November 1, 2014

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

February 11, 2016

Record last verified: 2016-02

Locations

DE(1)