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

Cardiac Output Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05508711
• Other study ID #: B4062021000220
• Status: Completed
• Start date: October 1, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: August 2022
• Source: Université Libre de Bruxelles
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 30, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Output

Intervention

Device:
• 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).

Locations

Country	Name	City	State
Belgium	Université Libre de Bruxelles	Brussel	Brussels-Capital

Sponsors (1)

Lead Sponsor	Collaborator
Université Libre de Bruxelles

Country where clinical trial is conducted

Belgium, 

References & Publications (6)

Maeda T, Hamaguchi E, Kubo N, Shimokawa A, Kanazawa H, Ohnishi Y. The accuracy and trending ability of cardiac index measured by the fourth-generation FloTrac/Vigileo system™ and the Fick method in cardiac surgery patients. J Clin Monit Comput. 2019 Oct;33(5):767-776. doi: 10.1007/s10877-018-0217-1. Epub 2018 Nov 7. — View Citation

Mayer J, Boldt J, Wolf MW, Lang J, Suttner S. Cardiac output derived from arterial pressure waveform analysis in patients undergoing cardiac surgery: validity of a second generation device. Anesth Analg. 2008 Mar;106(3):867-72, table of contents. doi: 10.1213/ane.0b013e318161964d. Retraction in: Anesth Analg. 2011 May;112(5):1074. — View Citation

McLean AS, Huang SJ, Kot M, Rajamani A, Hoyling L. Comparison of cardiac output measurements in critically ill patients: FloTrac/Vigileo vs transthoracic Doppler echocardiography. Anaesth Intensive Care. 2011 Jul;39(4):590-8. — View Citation

Pearse RM, Harrison DA, MacDonald N, Gillies MA, Blunt M, Ackland G, Grocott MP, Ahern A, Griggs K, Scott R, Hinds C, Rowan K; OPTIMISE Study Group. Effect of a perioperative, cardiac output-guided hemodynamic therapy algorithm on outcomes following major — View Citation

Suehiro K, Tanaka K, Mikawa M, Uchihara Y, Matsuyama T, Matsuura T, Funao T, Yamada T, Mori T, Nishikawa K. Improved Performance of the Fourth-Generation FloTrac/Vigileo System for Tracking Cardiac Output Changes. J Cardiothorac Vasc Anesth. 2015;29(3):656-62. doi: 10.1053/j.jvca.2014.07.022. Epub 2014 Nov 14. — View Citation

Vender JS. Clinical utilization of pulmonary artery catheter monitoring. Int Anesthesiol Clin. 1993 Summer;31(3):57-85. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To verify the FloTrac/Vigileo's ability to estimate cardiac output (L/min) in horizontal supine position.	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.	Baseline
Primary	To verify the FloTrac/Vigileo's ability to estimate cardiac output (L/min) in Trendelenburg position.	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.	Baseline
Primary	To verify the FloTrac/Vigileo's ability to estimate cardiac output (L/min) in reverse Trendelenburg position.	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.	Baseline