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

Université Libre de Bruxelles

Status: Completed

Conditions: Cardiac Output

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

Study type: Observational

Funder types: Other

Identifiers

NCT05508711

B4062021000220

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

40 participants in 2 patient groups

Group 1

Description:

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.

Treatment:

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

Group 2

Description:

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.

Treatment:

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