Clinical trial NCT05508711: Comparability of Transesophageal Echocardiography and FloTrac/Vigileo System Three Different Positions
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Output
Keywords: Cardiac output monitoring
Mini-invasive
Lead sponsor: Université Libre de Bruxelles
Sponsor class: OTHER
First posted: 2022-08-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients without heart disease or hemodynamic instability scheduled for elective pancreatic, bladder or liver surgery requiring invasive monitoring and Trendelenburg position during the procedure.

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.


Eligibility criteria: 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

Primary outcomes:
measure: To verify the FloTrac/Vigileo's ability to estimate cardiac output (L/min) in horizontal supine position.
timeFrame: Baseline
measure: To verify the FloTrac/Vigileo's ability to estimate cardiac output (L/min) in Trendelenburg position.
timeFrame: Baseline
measure: To verify the FloTrac/Vigileo's ability to estimate cardiac output (L/min) in reverse Trendelenburg position.
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: Université Libre de Bruxelles
state: Brussels-Capital
Study officials:
affiliation: Université Libre de Bruxelles
name: Lucélia FERNANDES RICCIARDI, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vender JS. Clinical utilization of pulmonary artery catheter monitoring. Int Anesthesiol Clin. 1993 Summer;31(3):57-85. doi: 10.1097/00004311-199331030-00006.
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.
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. doi: 10.1177/0310057X1103900409.
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.
citation: 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.
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 gastrointestinal surgery: a randomized clinical trial and systematic review. JAMA. 2014 Jun 4;311(21):2181-90. doi: 10.1001/jama.2014.5305.