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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03517189
Enrollment
40
Registered
2018-05-07
Start date
2017-05-15
Completion date
2019-05-31
Last updated
2018-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aorta No-touch, Cardiac Surgery

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.

Interventions

PROCEDUREAorta no-touch

Participants will be submitted to aorta no-touch off-pump coronary artery bypass surgery.

Sponsors

Federal University of São Paulo
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in central venous pressureThe 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 heart rateThe 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 mean arterial blood pressureThe 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 saturationThe 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
Change in continuous cardiac indexThe 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 stroke volumeThe 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

Secondary

MeasureTime frameDescription
Evaluate lactate levelsImmediate postoperative period, at the admission on the intensive care unitEvaluation of the lactate levels in the immediate postoperative

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026