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

Completed

• Conditions: Cardiac Output
• Interventions: Device: FloTrac/Vigileo system (© Edwards Lifesciences) (Edwards Lifesciences, Irvine, CA) device

• Registration Number: NCT05508711
• Lead Sponsor: Université Libre de Bruxelles

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-01
• Primary Completion: 2022-01-31
• Study Completion: 2022-06-30
• Status Verified: 2022-08
• Study First Submitted: 2022-08-15
• Study First Submitted QC: 2022-08-17
• Last Update Submitted: 2022-08-17
• Study First Posted: 2022-08-19
• Last Update Posted: 2022-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	FloTrac/Vigileo system (© Edwards Lifesciences) (Edwards Lifesciences, Irvine, CA) device	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.
Group 2	FloTrac/Vigileo system (© Edwards Lifesciences) (Edwards Lifesciences, Irvine, CA) device	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.

Primary Outcome Measures

Name	Time	Method
To verify the FloTrac/Vigileo's ability to estimate cardiac output (L/min) in Trendelenburg position.	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.	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.	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.

Trial Locations

Locations (1)

Université Libre de Bruxelles; 🇧🇪 Brussel, Brussels-Capital, Belgium