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Evaluation of Cardiac Functions in Deep Trendelenburg Position

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05685979
Enrollment
30
Registered
2023-01-17
Start date
2022-05-01
Completion date
2022-10-15
Last updated
2023-07-06

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

Conditions

Cardiovascular Complication, Hemodynamic Instability

Keywords

Deep Trendelenburg position, Robotic-assisted laparoscopic prostatectomy, Pressure recording analytical method, Transesophageal echocardiography, Cardiac cycle efficiency, Longitudinal Strain, Hemodynamic monitorization

Brief summary

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

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).

Interventions

PROCEDURERobotic-assisted laparoscopic prostatectomy in deep Trendelenburg position.

After general anesthesia induction, the patients were placed in the deep Trendelenburg position (at least 25°-45° upside down).

Sponsors

Acibadem University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to 100 Years
Healthy volunteers
No

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,

Design outcomes

Primary

MeasureTime frameDescription
Longitudinal strain rate (LSR) was measured for evaluating cardiac performanceLSR was measured at supine position and 10 minute after trendelenburg positionLSR (%) 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.
Cardiac cycle efficiency (CCE) was measured for evaluating cardiac performanceThe duration of the measurement was defined from one minute before induction to the end of the surgeryCCE(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)
Longitudinal strain (LS) was measured for evaluating cardiac performanceLS was measured at supine position and 10 minute after trendelenburg positionLS (%) 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.

Secondary

MeasureTime frameDescription
Cardiac index (CI) was measured for evaluating cardiac flowThe duration of the measurement was defined from one minute before induction to the end of the surgeryCardiac 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
Dp/Dt was measured to assess cardiac systolic functionThe duration of the measurement was defined from one minute before induction to the end of the surgeryDp/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.
Systolic arterial pressure (SAP) was measured for evaluating perfusion pressureThe duration of the measurement was defined from one minute before induction to the end of the surgerySystolic 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
Stroke volume variation (SVV) was measured for evaluation of volume statusThe duration of the measurement was defined from one minute before induction to the end of the surgeryStroke 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.
Mean arterial pressure (MAP) was measured for evaluating perfusion pressureThe duration of the measurement was defined from one minute before induction to the end of the surgeryMean 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
Heart rate (HR) was measured for evaluating heart ritmThe duration of the measurement was defined from one minute before induction to the end of the surgeryHeart 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.
Systemic vascular resistance index (SVRI) was measured for evaluating peripheric vascular resistanceThe duration of the measurement was defined from one minute before induction to the end of the surgerySystemic 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.
Diastolic arterial pressure (DAP) was measured for evaluating perfusion pressureThe duration of the measurement was defined from one minute before induction to the end of the surgeryDiastolic 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
Pulse pressure variation (PPV) was measured for evaluation of volume statusThe duration of the measurement was defined from one minute before induction to the end of the surgeryPulse 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.
Cardiac power output (CPO) was measured for evaluation of cardiac power reserveThe duration of the measurement was defined from one minute before induction to the end of the surgeryCardiac 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

Countries

Turkey (Türkiye)

Outcome results

None listed

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