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Completed

NCT Number: NCT05685979

Evaluation of Cardiac Functions in Deep Trendelenburg Position

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.

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Key information

Conditions

Hemodynamic Instability Cardiovascular Complication

Age range

18 year–100 year

Sex eligibility

Male

Study type

Observational

Primary location

Acibadem Altunizade Hospital

Istanbul, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Robotic-assisted laparoscopic prostatectomy in deep Trendelenburg position.

Procedure

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

Primary outcomes

  1. Cardiac cycle efficiency (CCE) was measured for evaluating cardiac performance

    Time frame: The duration of the measurement was defined from one minute before induction to the end of the surgery

    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)

  2. Longitudinal strain (LS) was measured for evaluating cardiac performance

    Time frame: LS was measured at supine position and 10 minute after trendelenburg position

    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.

  3. Longitudinal strain rate (LSR) was measured for evaluating cardiac performance

    Time frame: LSR was measured at supine position and 10 minute after trendelenburg position

    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.

Secondary outcomes

  1. Stroke volume variation (SVV) was measured for evaluation of volume status

    Time frame: The duration of the measurement was defined from one minute before induction to the end of the surgery

    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.

  2. Pulse pressure variation (PPV) was measured for evaluation of volume status

    Time frame: The duration of the measurement was defined from one minute before induction to the end of the surgery

    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.

  3. Cardiac power output (CPO) was measured for evaluation of cardiac power reserve

    Time frame: The duration of the measurement was defined from one minute before induction to the end of the surgery

    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

  4. Cardiac index (CI) was measured for evaluating cardiac flow

    Time frame: The duration of the measurement was defined from one minute before induction to the end of the surgery

    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

  5. Dp/Dt was measured to assess cardiac systolic function

    Time frame: The duration of the measurement was defined from one minute before induction to the end of the surgery

    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.

  6. Systolic arterial pressure (SAP) was measured for evaluating perfusion pressure

    Time frame: The duration of the measurement was defined from one minute before induction to the end of the surgery

    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

  7. Diastolic arterial pressure (DAP) was measured for evaluating perfusion pressure

    Time frame: The duration of the measurement was defined from one minute before induction to the end of the surgery

    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

  8. Mean arterial pressure (MAP) was measured for evaluating perfusion pressure

    Time frame: The duration of the measurement was defined from one minute before induction to the end of the surgery

    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

  9. Heart rate (HR) was measured for evaluating heart ritm

    Time frame: The duration of the measurement was defined from one minute before induction to the end of the surgery

    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.

  10. Systemic vascular resistance index (SVRI) was measured for evaluating peripheric vascular resistance

    Time frame: The duration of the measurement was defined from one minute before induction to the end of the surgery

    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.

Sponsors and collaborators

Lead sponsor

Acibadem University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 17, 2023
Registry last updated
Jul 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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