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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiac Output
- Sponsor
- Université Libre de Bruxelles
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- To verify the FloTrac/Vigileo's ability to estimate cardiac output (L/min) in Trendelenburg position.
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief 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.
Investigators
Lucelia Fernandes Ricciardi
Principal Investigator
Université Libre de Bruxelles
Eligibility Criteria
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
Outcomes
Primary Outcomes
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.
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.
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.