Hemodynamic Changes During Displacement of the Heart in the Aorta No-touch Off-pump Coronary Artery Bypass Surgery

Introduction: Aorta no-touch off-pump coronary artery bypass surgery (OPCAB) has been the recommended technique for treatment of patients with high-risk of neurological damage or stroke. However, the displacement of the heart to achieve suitable exposure for graft construction elicits hemodynamic changes, potentially requiring conversion to on-pump. Objective: The aim of this study is to evaluate the sequential changes of hemodynamic parameters in patients that undergo aorta no-touch OPCAB. Method: Patients that undergo aorta no-touch OPCAB will be evaluated. The FloTrac / PreSep / Vigileo ™ (Edwards Lifesciences) system will be used to continuously record heart rate (HR), mean arterial pressure (DBP), central venous pressure (CVP), continuous cardiac index, systolic volume , systolic volume variation (VVS) and central venous oxygen saturation (ScvO2). The parameters will be evaluated 5 min before, during and 5 min after each anastomosis (left anterior descending-LAD, posterior descending PD, marginal-OM and diagonal-Dg). Postoperative lactate will also be evaluated.

Study Overview

• Status: Unknown
• Conditions: Cardiac Surgery; Aorta No-touch
• Intervention / Treatment: Procedure: Aorta no-touch

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 04023062
      • Recruiting
      • Federal University of Sao Paulo
      • Contact: Solange Guizilini, PhD; Phone Number: +5511982887753; Email: s_guizilini@yahoo.com.br
      • Principal Investigator: Walter J. Gomes, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients with a diagnosis of coronary artery disease with indication of myocardial revascularization surgery

Exclusion Criteria:

• patients will be excluded if they presented clinically significant preoperative hepatic or renal dysfunction, thrombocytopenia, coagulopathy, or uncontrolled arrhythmia.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aorta no-touch; Aorta no-touch off-pump coronary artery bypass surgery.	Procedure: Aorta no-touch; Participants will be submitted to aorta no-touch off-pump coronary artery bypass surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in heart rate	By the FloTrac/PreSep/Vigileo™ system (Edwards Lifesciences), assessing the change in heart rate during procedures	The parameters will be assessed 5 min before, during and 5 min after each anastomosis (left anterior descending-LAD, posterior descending-PD, marginal-OM and diagonal-Dg).
Change in mean arterial blood pressure	By the FloTrac/PreSep/Vigileo™ system (Edwards Lifesciences), assessing the change in mean arterial blood pressure during procedures	The parameters will be assessed 5 min before, during and 5 min after each anastomosis (left anterior descending-LAD, posterior descending-PD, marginal-OM and diagonal-Dg).
Change in central venous pressure	By the FloTrac/PreSep/Vigileo™ system (Edwards Lifesciences), assessing the change in central venous pressure during procedures	The parameters will be assessed 5 min before, during and 5 min after each anastomosis (left anterior descending-LAD, posterior descending-PD, marginal-OM and diagonal-Dg).
Change in continuous cardiac index	By the FloTrac/PreSep/Vigileo™ system (Edwards Lifesciences), assessing the change in continuouns cardiac index during procedures	The parameters will be assessed 5 min before, during and 5 min after each anastomosis (left anterior descending-LAD, posterior descending-PD, marginal-OM and diagonal-Dg).
Change in stroke volume	By the FloTrac/PreSep/Vigileo™ system (Edwards Lifesciences), assessing the change in stroke volume during procedures	The parameters will be assessed 5 min before, during and 5 min after each anastomosis (left anterior descending-LAD, posterior descending-PD, marginal-OM and diagonal-Dg).
Change in central venous oxygen saturation	By the FloTrac /PreSep/Vigileo™ system (Edwards Lifesciences), assessing the change in central venous oxygen saturation during procedures	The parameters will be assessed 5 min before, during and 5 min after each anastomosis (left anterior descending-LAD, posterior descending-PD, marginal-OM and diagonal-Dg).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate lactate levels	Evaluation of the lactate levels in the immediate postoperative	Immediate postoperative period, at the admission on the intensive care unit

Collaborators and Investigators

• Sponsor: Federal University of São Paulo

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2017
• Primary Completion (Anticipated): May 1, 2019
• Study Completion (Anticipated): May 1, 2019

Study Registration Dates

• First Submitted: April 12, 2018
• First Submitted That Met QC Criteria: May 4, 2018
• First Posted (Actual): May 7, 2018

Study Record Updates

• Last Update Posted (Actual): May 7, 2018
• Last Update Submitted That Met QC Criteria: May 4, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 63054016.1.0000.5505

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No