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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 |
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| Group 2 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FloTrac/Vigileo system (© Edwards Lifesciences) (Edwards Lifesciences, Irvine, CA) device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients without heart disease or hemodynamic instability scheduled for elective pancreatic, bladder or liver surgery requiring invasive monitoring and Trendelenburg position during the procedure.
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| Name | Affiliation | Role |
|---|---|---|
| Lucélia FERNANDES RICCIARDI, M.D. | Université Libre de Bruxelles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Université Libre de Bruxelles | Brussels | Brussels Capital | 1070 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8375911 | Background | Vender JS. Clinical utilization of pulmonary artery catheter monitoring. Int Anesthesiol Clin. 1993 Summer;31(3):57-85. doi: 10.1097/00004311-199331030-00006. | |
| 18292432 | Background | 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. |
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| 21823375 | Background | 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. doi: 10.1177/0310057X1103900409. |
| 25440654 | Background | 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. |
| 30406422 | Background | 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. |
| 24842135 | Result | 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 gastrointestinal surgery: a randomized clinical trial and systematic review. JAMA. 2014 Jun 4;311(21):2181-90. doi: 10.1001/jama.2014.5305. |