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

Not Applicable

• Conditions: Cardiac Surgery; Aorta No-touch
• Interventions: Procedure: Aorta no-touch

• Registration Number: NCT03517189
• Lead Sponsor: Federal University of São Paulo

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-15
• Status Verified: 2018-04
• Study First Submitted: 2018-04-12
• Study First Submitted QC: 2018-05-04
• Last Update Submitted: 2018-05-04
• Study First Posted: 2018-05-07
• Last Update Posted: 2018-05-07
• Primary Completion: 2019-05
• Study Completion: 2019-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aorta no-touch	Aorta no-touch	Aorta no-touch off-pump coronary artery bypass surgery.

Primary Outcome Measures

Name	Time	Method
Change in stroke volume	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).	By the FloTrac/PreSep/Vigileo™ system (Edwards Lifesciences), assessing the change in stroke volume during procedures
Change in continuous cardiac index	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).	By the FloTrac/PreSep/Vigileo™ system (Edwards Lifesciences), assessing the change in continuouns cardiac index during procedures
Change in heart rate	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).	By the FloTrac/PreSep/Vigileo™ system (Edwards Lifesciences), assessing the change in heart rate during procedures
Change in central venous pressure	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).	By the FloTrac/PreSep/Vigileo™ system (Edwards Lifesciences), assessing the change in central venous pressure during procedures
Change in mean arterial blood pressure	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).	By the FloTrac/PreSep/Vigileo™ system (Edwards Lifesciences), assessing the change in mean arterial blood pressure during procedures
Change in central venous oxygen saturation	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).	By the FloTrac /PreSep/Vigileo™ system (Edwards Lifesciences), assessing the change in central venous oxygen saturation during procedures

Secondary Outcome Measures

Name	Time	Method
Evaluate lactate levels	Immediate postoperative period, at the admission on the intensive care unit	Evaluation of the lactate levels in the immediate postoperative

Trial Locations

Locations (1)

Federal University of Sao Paulo; 🇧🇷 Sao Paulo, SP, Brazil