Evaluation of Cardiac Functions in Deep Trendelenburg Position

Evaluation of Cardiac Functions in Robotic-assisted Prostatectomy Surgery Performed Under 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.

Study Overview

• Status: Completed
• Conditions: Hemodynamic Instability; Cardiovascular Complication
• Intervention / Treatment: Procedure: Robotic-assisted laparoscopic prostatectomy in deep Trendelenburg position.

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).

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Acibadem Altunizade Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The patients with ASA (American Society Of Anesthesiology) physical status 1-3 who underwent RALP with intra-arterial blood pressure monitoring before anesthesia induction

Description

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,

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients undergoing robotic-assisted laparoscopic prostatectomy in deep Trendelenburg position.; 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.; After general anesthesia induction, the patients were placed in the deep Trendelenburg position (at least 25°-45° upside down).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Acibadem University

Publications and helpful links

General Publications

• Lestar M, Gunnarsson L, Lagerstrand L, Wiklund P, Odeberg-Wernerman S. Hemodynamic perturbations during robot-assisted laparoscopic radical prostatectomy in 45 degrees Trendelenburg position. Anesth Analg. 2011 Nov;113(5):1069-75. doi: 10.1213/ANE.0b013e3182075d1f. Epub 2011 Jan 13.
• Falabella A, Moore-Jeffries E, Sullivan MJ, Nelson R, Lew M. Cardiac function during steep Trendelenburg position and CO2 pneumoperitoneum for robotic-assisted prostatectomy: a trans-oesophageal Doppler probe study. Int J Med Robot. 2007 Dec;3(4):312-5. doi: 10.1002/rcs.165.
• Porpiglia F, Morra I, Lucci Chiarissi M, Manfredi M, Mele F, Grande S, Ragni F, Poggio M, Fiori C. Randomised controlled trial comparing laparoscopic and robot-assisted radical prostatectomy. Eur Urol. 2013 Apr;63(4):606-14. doi: 10.1016/j.eururo.2012.07.007. Epub 2012 Jul 20.
• Pawlik MT, Prasser C, Zeman F, Harth M, Burger M, Denzinger S, Blecha S. Pronounced haemodynamic changes during and after robotic-assisted laparoscopic prostatectomy: a prospective observational study. BMJ Open. 2020 Oct 5;10(10):e038045. doi: 10.1136/bmjopen-2020-038045.
• Ruppert M, Lakatos BK, Braun S, Tokodi M, Karime C, Olah A, Sayour AA, Hizoh I, Barta BA, Merkely B, Kovacs A, Radovits T. Longitudinal Strain Reflects Ventriculoarterial Coupling Rather Than Mere Contractility in Rat Models of Hemodynamic Overload-Induced Heart Failure. J Am Soc Echocardiogr. 2020 Oct;33(10):1264-1275.e4. doi: 10.1016/j.echo.2020.05.017. Epub 2020 Aug 7.
• Faragli A, Tanacli R, Kolp C, Abawi D, Lapinskas T, Stehning C, Schnackenburg B, Lo Muzio FP, Fassina L, Pieske B, Nagel E, Post H, Kelle S, Alogna A. Cardiovascular magnetic resonance-derived left ventricular mechanics-strain, cardiac power and end-systolic elastance under various inotropic states in swine. J Cardiovasc Magn Reson. 2020 Nov 30;22(1):79. doi: 10.1186/s12968-020-00679-z.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): October 15, 2022

Study Registration Dates

• First Submitted: January 6, 2023
• First Submitted That Met QC Criteria: January 6, 2023
• First Posted (Actual): January 17, 2023

Study Record Updates

• Last Update Posted (Actual): July 6, 2023
• Last Update Submitted That Met QC Criteria: July 5, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Transesophageal echocardiography; Pressure recording analytical method; Deep Trendelenburg position; Robotic-assisted laparoscopic prostatectomy; Cardiac cycle efficiency; Longitudinal Strain; Hemodynamic monitorization
• Other Study ID Numbers: ATADEK; 2022-20/05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No