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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-01

Study Completion Date

2022-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Cardiac Output

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

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

Intervention Type 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.

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

Intervention Type 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).

Interventions

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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).

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes