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Comparability of Transesophageal Echocardiography and FloTrac/Vigileo System Three Different Positions

NCT05508711 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2022-08-19

No results posted yet for this study

Summary

The use of cardiac output monitoring to guide intraoperative fluid management and inotropic drugs as part of a hemodynamic therapy algorithm reduce the complication rate in major abdominal surgery. The FloTrac/Vigileo system (© Edwards Lifesciences) (Edwards Lifesciences, Irvine, CA) device estimate cardiac output by using arterial pulse contour analysis. The accuracy of FloTrac/Vigileo have been proven in patients with normal cardiac index. Most of studies regarding FloTrac/Vigileo were performed in patients in horizontal supine position, which is not usually the reality in the operation theater during abdominal surgery. Therefore, the investigators realized this monocentric prospective clinical trial to study the accuracy and trending ability of the fourth generation FloTrac/Vigileo system cardiac output estimation in three different positions (horizontal supine, Trendelenburg and reverse Trendelenburg positions) in anesthetized patients undergoing elective major abdominal surgery. The reference method of cardiac output measurement used was the transesophageal echocardiography.

Conditions

  • Cardiac Output

Interventions

DEVICE

FloTrac/Vigileo system (© Edwards Lifesciences) (Edwards Lifesciences, Irvine, CA) device

Concomitant cardiac output measurement with transesophageal echocardiography and with the FloTrac/Vigileo system (© Edwards Lifesciences) (Edwards Lifesciences, Irvine, CA) device in 3 different positions (horizontal supine, Trendelenburg and reverse Trendelenburg position).

Sponsors & Collaborators

  • Université Libre de Bruxelles

    lead OTHER

Principal Investigators

  • Lucélia FERNANDES RICCIARDI, M.D. · Université Libre de Bruxelles

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2022-01-31
Completion
2022-06-30

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05508711 on ClinicalTrials.gov