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Completed

NCT Number: NCT05508711

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

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.

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Key information

Conditions

Cardiac Output

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Université Libre de Bruxelles

Brussels, Brussels Capital, 1070, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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).

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Université Libre de Bruxelles

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 19, 2022
Registry last updated
Aug 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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