Evaluation of Cardiac Functions in Deep Trendelenburg Position

NCT05685979 | Completed

• 1 other identifier: ATADEK; 2022-20/05
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodynamic Instability; Cardiovascular Complication

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (10)

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

  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

  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

  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

  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

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

Study Arms (1)

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.

Interventions

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).

Patients undergoing robotic-assisted laparoscopic prostatectomy in deep Trendelenburg position.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (1)

Acibadem Altunizade Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 22840353 BACKGROUND

• 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.

  PMID: 18200624 BACKGROUND

• 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.

  PMID: 21233502 BACKGROUND

• 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.

  PMID: 33020097 BACKGROUND

• 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.

  PMID: 32778499 BACKGROUND

• 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.

  PMID: 33256761 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2023
• First Posted: January 17, 2023
• Study Start: May 1, 2022
• Primary Completion: September 30, 2022
• Study Completion: October 15, 2022
• Last Updated: July 6, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)