Evaluation of Cardiac Functions in Deep Trendelenburg Position

Study Overview
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Brief Summary
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Robotic-assisted laparoscopic prostatectomy (RALP) is a surgical method with good short-term results and accepted as the gold standard because of its minimal invasiveness. The pneumoperitoneum and deep Trendelenburg position (at least 25°-45° upside down) required for RALP surgeries can cause significant pathophysiological changes in both the pulmonary and cardiac systems, as well as complicate hemodynamic management. In this study, investigators aimed to determine the changes in the cardiovascular system during deep Trendelenburg position with the hemodynamic parameters monitored by the pressure record analytical method (PRAM) and the Longitudinal Strain measured with simultaneous transesophageal echocardiography.

Detailed Description
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RALP is the gold standard surgical technique in prostate surgery. Many Robotic-laparoscopic surgical techniques also require the intraoperative deep Trendelenburg position. However, the possible side effects of the deep Trendelenburg position on the cardiovascular system during surgery are unknown. Although the Trendelenburg position is a life-saving maneuver in hypovolemic patients, it also carries undesirable risks. Although the increase in venous return is expected to protect the cardiac output (CO) in the deep Trendelenburg position, the increase in intrathoracic pressure due to the intraperitoneal pressure may cause deterioration in venous return and a decrease in CO . In addition, the changing heart configuration in the deep Trendelenburg position may also cause an increase in the workload of the heart. Therefore, the need to evaluate hemodynamic management with advanced monitoring techniques, including fluid therapy in the perioperative period, has arisen in patients undergoing RALP. The pressure Recording Analytical Method (PRAM), is one of the most up-to-date monitoring methods designed for continuous CO measurement derived from the arterial pressure wave analysis, with a high signal sampling rate (1000 Hz). Many studies have shown that PRAM is a reliable monitoring method in major surgery. Cardiac Cycle Efficiency (CCE), which the PRAM method adds to our daily practice, is an index that defines hemodynamic performance in terms of energy consumption and efficiency. It can be expressed as the ratio of systolic energy performance to the total energy expenditure of the cardiac cycle and indicates the ability of the cardiovascular system to maintain homeostasis at different energy levels. However, data on how cardiac functions change in the deep Trendelenburg position are still limited. In this study, investigators aimed to demonstrate the reliability of the CCE value through its correlation with the Longitudinal Strain (LS) by observing the effect of the deep Trendelenburg position in RALP surgeries on cardiac functions using PRAM and Transesophageal Echocardiography (TEE).

Official Title
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Evaluation of Cardiac Functions in Robotic-assisted Prostatectomy Surgery Performed Under Deep Trendelenburg Position

Conditions
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Hemodynamic Instability, Cardiovascular Complication

Intervention / Treatment
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* Procedure: Robotic-assisted laparoscopic prostatectomy in deep Trendelenburg position.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with American Society Of Anesthesiology physical status 1-3 Underwent Robotic-assisted laparoscopic prostatectomy Patients with intra-arterial blood pressure monitoring before anesthesia induction. .Exclusion Criteria: Under 18 years of age Arrhythmia (atrial fibrillation, frequent premature beat) History of myocardial infarction in the last 3 months Heart failure Severe pre-existing lung disease Severe valvular heart disease Chronic renal disease on dialysis,

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients undergoing robotic-assisted laparoscopic prostatectomy in deep Trendelenburg position.<br>Patients with ASA( American Society of Anesthesiologists) physical status 1-3 who underwent robotic-assisted laparoscopic prostatectomy in deep Trendelenburg position. | Procedure: Robotic-assisted laparoscopic prostatectomy in deep Trendelenburg position.<br>* After general anesthesia induction, the patients were placed in the deep Trendelenburg position (at least 25°-45° upside down).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac cycle efficiency (CCE) was measured for evaluating cardiac performance | CCE(unit) indicates the ability of the cardiovascular system to maintain homeostasis at different energy levels. CCE was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy) | The duration of the measurement was defined from one minute before induction to the end of the surgery | 
| Longitudinal strain (LS) was measured for evaluating cardiac performance | LS (%) is a parameter that shows the percentage of dimensional change that occurs in the heart muscle. It is an indicator of the systolic functions of the left ventricle. LS was calculated by intraoperative transesophageal echocardiography. | LS was measured at supine position and 10 minute after trendelenburg position | 
| Longitudinal strain rate (LSR) was measured for evaluating cardiac performance | LSR (%) is a parameter that shows the rate of dimensional change that occurs in the heart muscle. It is an indicator of the systolic functions of the left ventricle. LSR was calculated by intraoperative transesophageal echocardiography. | LSR was measured at supine position and 10 minute after trendelenburg position | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke volume variation (SVV) was measured for evaluation of volume status | Stroke volume variation (SVV,%), was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy). SVV is a parameter used to asses cardiac preload and fluid responsiveness. | The duration of the measurement was defined from one minute before induction to the end of the surgery | 
| Pulse pressure variation (PPV) was measured for evaluation of volume status | Pulse pressure variation (PPV,%) was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy). PPV is a parameter used to asses cardiac preload and fluid responsiveness. | The duration of the measurement was defined from one minute before induction to the end of the surgery | 
| Cardiac power output (CPO) was measured for evaluation of cardiac power reserve | Cardiac power output (CPO, Watt) was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy). CPO is a parameter used to asses cardiac reserve | The duration of the measurement was defined from one minute before induction to the end of the surgery | 
| Cardiac index (CI) was measured for evaluating cardiac flow | Cardiac index (CI, L/min/m2), was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy). CI is a parameter used to asses cardiac stroke volume | The duration of the measurement was defined from one minute before induction to the end of the surgery | 
| Dp/Dt was measured to assess cardiac systolic function | Dp/Dt(mmHg/msn), was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy). Dp/Dt is a parameter used to asses cardiac contractility. | The duration of the measurement was defined from one minute before induction to the end of the surgery | 
| Systolic arterial pressure (SAP) was measured for evaluating perfusion pressure | Systolic arterial pressure (SAP- mm/Hg) was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy). SAP is a parameter used to assess the pressure of the arterial system during cardiac systole | The duration of the measurement was defined from one minute before induction to the end of the surgery | 
| Diastolic arterial pressure (DAP) was measured for evaluating perfusion pressure | Diastolic arterial pressure (DAP, mm/Hg) was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy). DAP is a parameter used to assess the pressure of the arterial system during cardiac diastole | The duration of the measurement was defined from one minute before induction to the end of the surgery | 
| Mean arterial pressure (MAP) was measured for evaluating perfusion pressure | Mean arterial pressure (MAP, mm/Hg) was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy). MAP is a parameter used to assess organ perfusion | The duration of the measurement was defined from one minute before induction to the end of the surgery | 
| Heart rate (HR) was measured for evaluating heart ritm | Heart rate( HR, bpm) was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy). HR is a parameter used to assess the cardiac rate. | The duration of the measurement was defined from one minute before induction to the end of the surgery | 
| Systemic vascular resistance index (SVRI) was measured for evaluating peripheric vascular resistance | Systemic vascular resistance index (SVRI, dyn*s/cm5*m2) was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy). SVRI is a parameter used to assess the resistance to blood flow offered by all of the systemic vasculatures, excluding the pulmonary vasculature. | The duration of the measurement was defined from one minute before induction to the end of the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deep Trendelenburg position, Robotic-assisted laparoscopic prostatectomy, Pressure recording analytical method, Transesophageal echocardiography, Cardiac cycle efficiency, Longitudinal Strain, Hemodynamic monitorization