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

August 17, 2022 updated by: Lucelia Fernandes Ricciardi, Université Libre de Bruxelles

Comparability of Transesophageal Echocardiography and Continuous Mini-invasive FloTrac/Vigileo System (© Edwards Lifesciences) for the Determination of Cardiac Output in Three Different Positions During General Anesthesia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Brussels-Capital
      • Brussel, Brussels-Capital, Belgium, 1070
        • Université libre de Bruxelles

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients without heart disease or hemodynamic instability scheduled for elective pancreatic, bladder or liver surgery requiring invasive monitoring and Trendelenburg position during the procedure.

Description

Inclusion Criteria:

  • patients scheduled for elective pancreatic, bladder or liver surgery requiring invasive monitoring and Trendelenburg position during the procedure

Exclusion Criteria:

  • age under 18 years
  • weight under 40 kg
  • preoperative left ventricular ejection fraction (LVEF) less than 45%
  • severe heart valve disease
  • known intra-and/or extracardiac shunt
  • pulmonary hypertension
  • preoperative circulatory shock with need for hemodynamic inotropic support
  • redo surgery
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
  1. st cardiac output measurement (horizontal supine position): Transesophageal echocardiographic cardiac output measurements, data recorded and in the meantime the data of the FloTrac system (© Edwards Lifesciences) monitor recorded also.
  2. nd cardiac output measurement (Trendelenburg position): The operating table was then tilted in - 30 ° Trendelenburg (head-down) position. Echocardiographic measurements and FloTrac system (© Edwards Lifesciences) data were recorded.
  3. rd cardiac output measurement: The patients were positioned from Trendelenburg to reverse-Trendelenburg, the above-described data were recorded again.
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).
Group 2
  1. st cardiac output measurement (horizontal supine position): Transesophageal echocardiographic cardiac output measurements, data recorded and in the meantime the data of the FloTrac system (© Edwards Lifesciences) monitor recorded also.
  2. nd cardiac output measurement (reverse Trendelenburg position): The operating table was then tilted in + 30 ° reverse Trendelenburg (head-up) position. Echocardiographic measurements and FloTrac system (© Edwards Lifesciences) data were recorded.
  3. rd cardiac output measurement: The patients were positioned from reverse Trendelenburg to Trendelenburg, the above-described data were recorded again.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To verify the FloTrac/Vigileo's ability to estimate cardiac output (L/min) in horizontal supine position.
Time Frame: Baseline
To study the fourth generation FloTrac/Vigileo system accuracy to estimate cardiac output (L/min) in horizontal supine position in anesthetized patients undergoing elective major abdominal surgery. The reference method of cardiac output (L/min) measurement used was the transesophageal echocardiography. The two cardiac output measurement techniques were assessed using Bland-Altman method.
Baseline
To verify the FloTrac/Vigileo's ability to estimate cardiac output (L/min) in Trendelenburg position.
Time Frame: Baseline
To study the fourth generation FloTrac/Vigileo system accuracy to estimate cardiac output (L/min) in Trendelenburg position in anesthetized patients undergoing elective major abdominal surgery. The reference method of cardiac output (L/min) measurement used was the transesophageal echocardiography. The two cardiac output measurement techniques were assessed using Bland-Altman method.
Baseline
To verify the FloTrac/Vigileo's ability to estimate cardiac output (L/min) in reverse Trendelenburg position.
Time Frame: Baseline
To study the fourth generation FloTrac/Vigileo system accuracy to estimate cardiac output (L/min) in reverse Trendelenburg position in anesthetized patients undergoing elective major abdominal surgery. The reference method of cardiac output (L/min) measurement used was the transesophageal echocardiography. The two cardiac output measurement techniques were assessed using Bland-Altman method.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université Libre de Bruxelles

Investigators

  • Principal Investigator: Lucélia FERNANDES RICCIARDI, M.D., Université libre de Bruxelles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Actual)

January 31, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

August 15, 2022

First Submitted That Met QC Criteria

August 17, 2022

First Posted (Actual)

August 19, 2022

Study Record Updates

Last Update Posted (Actual)

August 19, 2022

Last Update Submitted That Met QC Criteria

August 17, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • B4062021000220

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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